8,513 Pharmaceutical Engineer jobs in the United States

• Design, develop, and optimize pharmaceutical manufacturing processes (e.g., fermentation, purification, formulation, aseptic filling) in accordance with cGMP regulations.
• Lead process validation activities, including IQ, OQ, PQ, and PPQ, ensuring all processes meet regulatory requirements and internal standards.
• Troubleshoot process deviations and equipment malfunctions, identifying root causes and implementing effective corrective and preventive actions (CAPAs).
• Collaborate with R&D, Manufacturing, Quality Assurance, and Regulatory Affairs teams to ensure seamless technology transfer and process scale-up.
• Develop and review process documentation, including batch records, SOPs, and validation protocols/reports.
• Conduct process risk assessments using methodologies like FMEA to identify and mitigate potential quality issues.
• Evaluate and implement new process technologies and equipment to improve efficiency, yield, and product quality.
• Provide technical expertise and mentorship to junior engineers and manufacturing personnel.
• Analyze process data, identify trends, and recommend strategies for continuous process improvement.
• Ensure adherence to all safety, environmental, and cGMP guidelines throughout all process activities.

• Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or a related field. PhD is a plus.
• Minimum of 6 years of experience in process engineering within the pharmaceutical or biotechnology industry, with a strong understanding of cGMP regulations.
• Demonstrated experience in process scale-up, validation, and optimization of biopharmaceutical or small molecule manufacturing.
• Proficiency in relevant manufacturing unit operations and equipment.
• Strong knowledge of FDA regulations and ICH guidelines.
• Excellent analytical, problem-solving, and critical-thinking skills.
• Proven ability to manage projects and work effectively in cross-functional teams.
• Strong technical writing and communication skills.
• Experience with statistical analysis and process modeling software is beneficial.
• Adaptability and ability to thrive in a fast-paced, dynamic environment.

• Lead the design, development, and optimization of pharmaceutical manufacturing processes, including upstream and downstream operations for biologics and small molecules.
• Develop and execute process validation strategies, protocols, and reports in accordance with cGMP guidelines.
• Troubleshoot and resolve complex process-related issues, identifying root causes and implementing effective corrective and preventative actions (CAPAs).
• Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure seamless technology transfer and scale-up of new products.
• Conduct process hazard analyses (PHAs) and implement robust safety measures to ensure a safe working environment.
• Manage and mentor a team of process engineers, providing technical guidance and fostering professional development.
• Stay current with industry best practices, emerging technologies, and regulatory requirements (FDA, EMA, etc.) relevant to pharmaceutical manufacturing.
• Develop and maintain detailed process documentation, including batch records, SOPs, and validation master plans.
• Lead continuous improvement initiatives to enhance process efficiency, reduce costs, and improve product quality.
• Participate in regulatory inspections and audits, providing technical expertise and support.

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, or a related field.
• Minimum of 7 years of experience in pharmaceutical process engineering, with a strong focus on process development, scale-up, and validation.
• In-depth knowledge of cGMP regulations and guidelines for pharmaceutical manufacturing.
• Proven experience with various pharmaceutical manufacturing technologies, such as bioreactors, filtration systems, chromatography, lyophilization, and sterile filling.
• Strong analytical and problem-solving skills, with the ability to apply engineering principles to complex manufacturing challenges.
• Excellent project management skills, with experience leading cross-functional teams.
• Proficiency in process simulation software (e.g., Aspen Plus) and statistical analysis tools is a plus.
• Exceptional communication, presentation, and interpersonal skills.
• Ability to work independently and manage multiple projects effectively in a remote setting.
• Strong understanding of quality systems and regulatory compliance within the pharmaceutical industry.

• Design, develop, and optimize chemical processes for pharmaceutical manufacturing.
• Conduct process development studies, including feasibility, scale-up, and validation.
• Develop process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and equipment specifications.
• Perform mass and energy balance calculations.
• Implement and monitor process control strategies to ensure consistent product quality.
• Troubleshoot process deviations and implement corrective actions.
• Ensure all processes comply with GMP, FDA regulations, and safety standards.
• Collaborate with R&D, manufacturing, and quality teams on process improvements.
• Analyze process data to identify opportunities for efficiency and cost reduction.
• Author and review process validation reports and technical documentation.

• Bachelor's or Master's degree in Chemical Engineering or a related field.
• 5+ years of experience in chemical process engineering, preferably in the pharmaceutical or biopharmaceutical industry.
• In-depth knowledge of GMP, FDA regulations, and validation principles.
• Experience with process simulation software (e.g., Aspen Plus, HYSYS).
• Familiarity with reaction kinetics, thermodynamics, and separation processes.
• Strong analytical, problem-solving, and project management skills.
• Excellent technical writing and communication abilities.
• Ability to work independently and manage projects remotely.
• Experience with Lean Manufacturing or Six Sigma methodologies is a plus.

• Designing, developing, and optimizing chemical processes for pharmaceutical manufacturing.
• Conducting process simulations and feasibility studies.
• Developing and implementing process improvements to enhance yield, efficiency, and product quality.
• Troubleshooting process deviations and implementing corrective and preventative actions (CAPAs).
• Ensuring all processes comply with GMP, FDA regulations, and safety standards.
• Developing and validating new manufacturing processes.
• Generating process documentation, including batch records, SOPs, and validation reports.
• Collaborating with R&D, Quality Assurance, and Manufacturing teams.
• Participating in Process Hazard Analyses (PHAs) and risk assessments.
• Monitoring key process performance indicators and reporting on findings.
• Providing technical support and training to production personnel.
• Evaluating and implementing new process technologies and equipment.

• Bachelor's or Master's degree in Chemical Engineering or a related field.
• 3-5 years of experience in chemical process engineering, preferably within the pharmaceutical or biotechnology industry.
• Strong understanding of chemical engineering principles, including mass transfer, heat transfer, and reaction kinetics.
• Experience with process simulation software (e.g., Aspen Plus, HYSYS).
• Knowledge of GMP and regulatory requirements in pharmaceutical manufacturing.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication abilities.
• Ability to work effectively in a team-oriented environment.
• Experience with scale-up from laboratory to pilot to commercial production is desirable.
• Familiarity with process control systems.

Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Validation Engineer.

This position, in the Manufacturing and Formulations Services department, requires a Bachelor s degree or higher in a scientific or engineering discipline with either 3 years of experience or an equivalent combination of education and experience in a GMP laboratory or manufacturing environment. Special consideration given to candidates with experience with automated filling equipment especially in a sterile manufacturing environment.

Responsibilities include: create and execute equipment installation and operational qualification/requalification, calibration, and preventative maintenance for manufacturing instruments and equipment, as well as facilities and utilities qualifications /develop Standard Operating Procedures and training materials for manufacturing equipment / perform Factory Acceptance Tests for new equipment at vendor sites/monitor ViewLinc and respond to excursions as needed/perform data trending and write reports, change requests, and deviations / communicate with clients, manufacturing and formulations management, and the quality group.

Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers.

QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility.

QCL is an equal opportunity employer.