Manufacturing Engineer

Aiken, South Carolina MRINetwork Jobs

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MR Lowcountry, LLC .

Nebo, NC 28761 Telephone:

Manufacturing Engineer

Aiken, SC area On-site

The company is a next-generation industrial biotechnology company headquartered in Massachusetts that produces plant-based ingredients. They use a variety of patented and proprietary technologies to engineer microbes to produce specialty chemicals such as food ingredients, flavor materials, agricultural chemicals, and pharmaceuticals. The company works across industries and value chains to accelerate the transition to Bio Alternatives – better performing and more sustainable versions of complex molecules traditionally sourced from plants, animals, or fossil fuels. Our platform is proven to work across scales, bridging the Valley of Death between lab and manufacturing more efficiently and more reliably to deliver the benefits of synthetic biology today. We are seeking a self-motivated and highly organized individual to join our Engineering Department.

We are seeking a Manufacturing Engineer to support commercial scale biomanufacturing operations. The ideal candidate will play a key role in optimizing purification processes, driving operational excellence, and ensuring production efficiency and compliance in a GMP-regulated environment.

Why work for the company:

Opportunity – For motivated, results-oriented team members, our growth creates opportunities for personal and professional advancement.

Accountability – You are given the resources you need to succeed and the freedom to make it happen; in return, we hold each other accountable for our high expectations.

Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that come with working on the cutting edge.

Key Responsibilities:

  • Production Planning & Scheduling: Develop, coordinate, and maintain detailed downstream production plans to meet manufacturing targets, delivery timelines, and inventory requirements.
  • Process Optimization: Analyze and improve purification operations (chromatography, filtration, UF/DF) to reduce waste, increase yield, and enhance product quality in coordination with Process Engineering.
  • Operational Excellence Initiatives: Lead or support Lean Manufacturing, Six Sigma, and Kaizen projects to drive continuous improvement across downstream production areas.
  • Data-Driven Performance Tracking: Implement and monitor manufacturing KPIs (OEE, yield, cycle time) and leverage analytics to drive process improvement. Support the deployment of automation, robotics, and digital tools to enhance process traceability and efficiency.
  • Quality Assurance Integration: Collaborate with QA/QC teams to ensure full QA program compliance, establish SOPs, and resolve non-conformities.
  • Cost Reduction Projects: Identify and execute cost-saving initiatives through improved process efficiency, material utilization, and resource management.
  • Capacity Analysis: Evaluate production capacity, bottlenecks, and resource allocation to support strategic manufacturing decisions.
  • Cross-Functional Collaboration: Partner with design, maintenance, and supply chain teams to ensure manufacturability, process stability, and efficient material flow.
  • Training & Development: Collaborate on training operators and technicians on process changes, quality standards, and safety procedures. High involvement in the training program.
  • Sustainability, Environmental and Regulatory Compliance: Ensure operations comply with EHS standards and sustainability goals. Ensure do operations adhere to cGMP, ISO, and FDA regulatory requirements.
  • Standard Work Documentation: Develop and maintain process documentation, standard operating procedures (SOPs), and work instructions.
  • Root Cause Analysis: Lead problem-solving activities (5 Whys, Fishbone) to investigate process deviations and implement CAPA actions.

Qualifications:

Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a related field (Master’s preferred).

3–7 years of experience in biomanufacturing, preferably within downstream processing (DSP) operations.

Familiarity with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.

Strong analytical and problem-solving skills with proficiency in data-driven decision-making.

Excellent communication and collaboration skills across technical and operations teams.

Experience in GMP manufacturing environments and knowledge of automation and process control systems a plus

Other Duties: Please note this job description does not fully describe or provide a comprehensive list of all duties and responsibilities of the position. Duties and responsibilities, including essential functions, may vary amongst locations and/or individuals holding this position and may be added or changed without notice. All qualified applicants will receive consideration for employment and will not be discriminated against based on race, color, religion, sex, sexual orientation, national origin, age, disability, or protected veteran status. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. We are an Equal Opportunity Employer M/F/Vets/Disability.

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Machinist, Advanced Manufacturing & Design

29805 Aiken, South Carolina Savannah River National Laboratory

Posted 4 days ago

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Savannah River National Laboratory is seeking a Machinist to join a dynamic team in the Machine Shop of the Advanced Manufacturing & Design organization creating innovative solutions for the Savannah River Site, DOE complex and national security missions.

The candidate will work in the Advanced Engineering R&D Machine Shop and perform work from work orders, drawings, design documents and procedures to perform machining activities based on skills and knowledge obtained from training and/or previous experience. Candidate should demonstrate necessary knowledge and skills to program, set up, and operate CNC equipment and CAD-CAM Systems, operate material handling equipment, and inspect and/or test parts and equipment to determine functional condition. Meet physical requirements for the essential duties, which include working around rotating equipment, being able to lift up to 50 pounds, prolonged standing, climbing, bending, and twisting.

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Quality Scientist - Biotech Manufacturing

Aiken, South Carolina MRINetwork Jobs

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MR Lowcountry, LLC .

Nebo, NC 28761 Telephone:

Quality Scientist – Biotech Manufacturing (Foodstuff/KSM/API)

Aiken, SC area On-site

The company is a next-generation industrial biotechnology company headquartered in Massachusetts that produces plant-based ingredients. They use a variety of patented and proprietary technologies to engineer microbes to produce specialty chemicals such as food ingredients, flavor materials, agricultural chemicals, and pharmaceuticals. The company works across industries and value chains to accelerate the transition to Bio Alternatives – better performing and more sustainable versions of complex molecules traditionally sourced from plants, animals, or fossil fuels. Our platform is proven to work across scales, bridging the Valley of Death between lab and manufacturing more efficiently and more reliably to deliver the benefits of synthetic biology today. We are seeking a self-motivated and highly organized individual to join our Quality Department.

The Quality Scientist supports cGMP compliance across biotech manufacturing operations for foodstuff, key starting materials (KSM) and active pharmaceutical ingredients (API). This role is essential in ensuring the integrity, safety, and quality of regulated foodstuff, intermediate and drug substances produced using fermentation, enzymatic bioconversion, or precision fermentation technologies. The role involves deep interaction with manufacturing, analytical, regulatory, and supply chain teams to maintain compliance with FDA, ICH, EU GMP, and PIC/S expectations.

Why work for the company:

Opportunity – For motivated, results-oriented team members, our growth creates opportunities for personal and professional advancement.

Accountability – You are given the resources you need to succeed and the freedom to make it happen; in return, we hold each other accountable for our high expectations.

Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that come with working on the cutting edge.

Key Responsibilities:

Quality Systems & cGMP Oversight

  • Serve as the quality lead for one or more QMS elements: Change Control, Deviation Investigation, CAPA, and Supplier Quality, Audit

Management, Validation Lifecycles

  • Implement and maintain quality oversight for production of biotech-derived materials, including process validation, cleaning validation, and

analytical method validation.

  • Lead compliance gap assessments, internal audits, and coordinate responses to regulatory observations (FDA 483s etc.)
  • Ensure compliance with 21 CFR Part 210/211, ICH Q7, and EU GMP Part II (APIs).

Product Quality & Batch Review

  • Perform comprehensive batch record reviews and ensure timely QA disposition.
  • Support the generation and review of Master Production Records and Batch Production Records specific to biotech-derived materials.

Deviation Management & Investigations

  • Lead complex root cause investigations using QRM tools (5-Whys, FMEA, Ishikawa).
  • Author and approve deviation reports and associated CAPA plans, ensuring timely implementation and closure.
  • Support risk-based decision-making using tools aligned with ICH Q9 (R1) and site Quality Risk Management processes.

Audit and Regulatory Readiness

  • Support preparation for regulatory inspections (FDA, EMA, WHO PQ), customer audits, and internal audits.
  • Contributes to the preparation of quality sections for regulatory submissions (DMFs, CMC sections of INDs/NDAs).

Document Control & Training

  • Create and maintain SOPs, forms, and protocols associated with foodstuff/ KSM/API production and testing.
  • Train cross-functional staff on cGMP procedures related to fermentation-derived ingredients and complex biologically sourced APIs.

Required Qualifications:

  • Bachelor’s degree in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Microbiology, or related field. Master’s Degree preferred.
  • 7+ years of experience in pharmaceutical or biotechnology quality assurance, with a focus on API or fermentation-based manufacturing.
  • Strong knowledge of ICH Q7, EU GMP for APIs, FDA Guidance for Biotech APIs, and data integrity.
  • Familiarity with bioprocessing, microbial control strategies, and impurity profiling in biotech manufacturing.
  • Experience with QMS and QbD documentation.

Preferred Skills:

  • Experience supporting Drug Master Files (DMFs), QbD documentation, or CMC sections.
  • Prior involvement in precision fermentation or enzyme-catalyzed bioconversion operations is a strong asset.
  • Auditing experience (internal, external, or supplier).
  • ASQ-CQA, Six Sigma Green Belt, or equivalent GMP certifications preferred.

Key Competencies:

  • Strong technical writing, cGMP interpretation, and quality decision-making skills.
  • Ability to interpret process analytical data and translate into risk-based QA decisions.
  • Collaborative mindset with cross-functional teams (Manufacturing, Regulatory Affairs, and Supply Chain).

Working Conditions:

  • Based in Aiken, SC area , with potential for hybrid flexibility depending on company policy.
  • May require on-call rotation and occasional after-hours maintenance for critical systems.

Other Duties: Please note this job description does not fully describe or provide a comprehensive list of all duties and responsibilities of the position. Duties and responsibilities, including essential functions, may vary amongst locations and/or individuals holding this position and may be added or changed without notice. All qualified applicants will receive consideration for employment and will not be discriminated against based on race, color, religion, sex, sexual orientation, national origin, age, disability, or protected veteran status. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. We are an Equal Opportunity Employer M/F/Vets/Disability.

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Lead Manufacturing Associate - 1st Shift

30914 Augusta, Georgia Cardinal Health

Posted 2 days ago

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**_What Process Engineering contributes to Cardinal Health_**
Engineering is responsible for performing research and analyses to develop design options for components, products, systems and processes.
Process Engineering is responsible for analyzing and assessing supplier and in-house processes to determine process capability. Identify and drive process improvements. Support supplier assessment and selection process. Directs external resources / contractors as required.
**_Responsibilities:_**
+ Serve as a backup to supervisors, including coverage during weekends and other absences.
+ Support and lead operational excellence initiatives such as Kaizen events, 6S audits, and Gemba walks.
+ Partner with supervisors to drive performance, accountability, and continuous improvement.
+ Demonstrate professional behavior and effective communication when interacting with associates and leadership.
+ Act as a role model for leadership expectations while operating in an hourly capacity.
+ Assist in training and coaching associates to support business goals and team development.
+ Identify and escalate operational issues and improvement opportunities.
+ Maintain a strong presence on the floor to support safety, quality, and productivity standards.
**_Qualifications_**
+ 4+ years of experience, preferred
+ High School diploma, GED or equivalent, or equivalent work experience, preferred
+ Prior experience with Lean Manufacturing tools and principles preferred
+ Prior leadership experience in a manufacturing setting preferred
**_What is expected of you and others at this level_**
+ Applies extensive knowledge and company policies to complete a wide range of assignments
+ Demonstrates expert understanding of all levels of the job family and has thorough knowledge of jobs outside area of responsibility
+ Takes the lead in effectively applying new processes and skills in accomplishing assignments
+ May provide technical guidance and training to others
+ Maintains appropriate licenses, training and certifications
+ Works on complex problems that require independent action and a high degree of initiative to resolve issue
+ Makes recommendation for new or revised processes and has a role on the implementation
+ Adheres to all quality guidelines
+ Works with minimal degree of supervision
+ Has latitude to make decisions in exceptional circumstances within established guidelines
+ Provides guidance to less experienced team members
+ May have team leader responsibilities but does not formally supervise
**Anticipated hourly range:** $23.40 per hour - $38.62 per hour
**Bonus eligible:** Yes/No
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 10/31/25 *if interested in opportunity, please submit application as soon as possible.
The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
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Production Planning Manager - Industrial Manufacturing - Direct Hire

New
30910 Augusta, Georgia Softworld, a Kelly Company

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Production Planning Manager - Industrial Manufacturing Management - Direct Hire


Location: Augusta, GA

Direct Hire


We are seeking an experienced Manufacturing Manager to lead materials planning and inventory control functions within a dynamic manufacturing environment. This individual will play a critical role in ensuring material availability, maintaining accurate inventory, and supporting efficient production flow while leading a small team of materials and inventory professionals.

Key Responsibilities

  • Oversee material planning, production scheduling, and inventory control to support timely and accurate product delivery.
  • Lead the release, control, and tracking of shop floor work orders through completion.
  • Proactively resolve material shortages and supplier delivery issues; recommend long-term solutions to strengthen the supply chain.
  • Monitor production, capacity, and inventory reports to ensure proper material flow and alignment with production schedules.
  • Manage supplier relationships and coordinate with engineering, quality, and procurement teams to address material concerns.
  • Supervise and mentor inventory control staff, providing direction, feedback, and support to meet organizational goals.
  • Partner with corporate supply chain and procurement leaders on continuous improvement initiatives.


Qualifications

  • Bachelor’s degree in Business, Supply Chain, Operations Management, or related field.
  • 8+ years of experience in materials management, purchasing, or production planning within a manufacturing environment.
  • Strong knowledge of production planning, supply chain management, and inventory control best practices.
  • Demonstrated leadership skills with experience supervising teams.
  • APICS/CPIM, Lean, or Six Sigma certification strongly preferred.
  • Proven ability to forecast, strategically plan, and work collaboratively across functions.


This role offers an opportunity to directly impact operations in a growing manufacturing business, with visibility to leadership and room to drive meaningful process improvements.

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Quality Control Laboratory Analyst

North Augusta, South Carolina Halocarbon

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Description:

The Quality Control (QC) Laboratory Analyst is responsible for supporting all Halocarbon activities related to analysis in the QC lab. This role supports the Specialty Chemical and Pharmaceutical production processes at Halocarbon and operates on a four on four off 12-hour rotating shift. The QC Laboratory Analyst is expected to prioritize tasks based on communication from supervision and team strategy. The QC Analyst should be a well-organized individual that demonstrates excellent safety awareness and bring a positive energy to the team. They should be a team player with the ability to communicate clearly and effectively in Quality and cross functionally.

The QC Lab Analyst will follow the direction of the QC leadership in assuring that Halocarbon meets cGMP, QMS, regulatory, and customer quality agreements. Operate various analytical instrumentation (i.e., Gas Chromatograph) to execute established test methods for analysis of a wide variety of products in support of a growing business. Operate, read, interpret, and practically apply regulations, industry guidelines in the cGMP (pharmaceutical) and specialty chemical quality management systems. Adhere to the laboratory Safety Chemical Hygiene plan to ensure compliance with 29 CFR . Demonstrate and model quality stewardship excellence through participation in and compliance with Halocarbon policies, management systems, procedures, teams, and training. Follow QC documentation and ensure that it is completed per the management system and regulatory requirements.

Duties & Responsibilities

  • Adhere to plant safety requirements and plant policies and promote a positive safety culture, leading by example.
  • Embrace, demonstrate and promote Halocarbon’s Core Values of Caring, Curiosity, Collaboration, and Competitive Spirit.
  • Adhere to all current Good Manufacturing Practices (cGMP) and Halocarbon QMS requirements.
  • Troubleshoot analytical laboratory equipment malfunctions.
  • Record data into logbooks and data sheets accurately per Halocarbon and cGMP procedures.
  • Perform calibration and preventative maintenance on lab equipment and instruments.
  • Prioritize and perform material and data analysis.
  • Set up laboratory apparatus.
  • Perform assigned maintenance and organization of work areas.
  • Execute the laboratory reagents and solutions program.
  • Report all accidents and incidents.
  • Maintain laboratory inventory system

Analytical Ability/Problem Solving/Technical skills – List minimum level of skills (i.e. computer/software proficiency, level of analytical complexity, problem solving scope, etc.)

  • Good written and verbal communication abilities.
  • Good analytical abilities to review and interpret information.
  • Exceptional attention to detail with high standards of excellence.
  • Adaptable and reacts positively to change.
  • Strong organization and time management skills.
  • cGMP and/or quality system knowledge is desired.
  • Able to work overtime as needed to accomplish goals
  • Experience with computer software (Word, Outlook, Excel, Access, and PowerPoint).
  • Excellent organizational skills with a strong work ethic and continuous improvement mentality.
  • Strong self-awareness with a steady personality, adaptable and reacts positively in a dynamic environment.

Level of Supervision Needed – List the type and extent of supervision received by this job (i.e., accountability, project management, etc.)

  • Ability to work autonomously and proactively with supervisory direction.
Requirements:

Education and/or Experience – List the minimum level of education and/or experience required to perform the duties and responsibilities of this job.

  • Bachelor’s degree in science (e.g., biology or chemistry) is preferred.
  • High School Diploma with relevant work experience will be considered.
  • cGMP and/or quality system knowledge is desired.
  • General math aptitude is required.

Safety/Essential Functions

  • Must be capable of lifting containers weighing up to 50 pounds.
  • Must be able to evacuate the plant, reporting to appropriate assigned muster point, in the event of an emergency or drill.
  • Must be able to work in an environment where chemical odors may exist at permissible threshold limits of exposure.
  • Must be able to climb and descend stairs and ladders.
  • Must be able to use all available or assigned personal protective equipment and tools.
  • Must be able to safely handle hazardous chemicals on a regular basis.


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