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#2531 Validation Engineer - Pharmaceutical

Our client is a Fortune 500 Pharmaceutical Company with Global reach. They are currently looking for a strong Validation Engineer to join their tenured Validation team.

Key responsibilities for this role include:

• Provide direction, reviews and provides Quality approval for design qualification documents, validation protocols, summary reports, discrepancy reports and CPV reports.
• Provides the Quality Assurance review and approval of Engineering, Calibration, Facility Maintenance, Production Support (Maintenance), Technical Services and IT procedures and forms.
• Authors protocols and reports as required/assigned.
• Perform validation planning and tracking.
• Assist in the development and maintenance of the procedures defining the validation program at MTI.
• Participates in the evaluation of changes to validated systems to ensure the validate state is maintained. Provides direction, reviews and approves proposed changes and facilitates decision making regarding the extent of any re-validation requirements.
• Assist in the compilation of periodic reports required by the validation program.

The minimum qualifications for this role are:

• Bachelor of Science degree (or equivalent) and 7 + years in a pharmaceutical cGMP environment is required. A combination of experience and/or education will be taken into consideration.
• Must possess a working knowledge of Pharmaceutical validation and cGMP concepts.

• Design, develop, optimize, and scale-up pharmaceutical manufacturing processes.
• Lead process validation activities, including protocol development, execution, and report generation.
• Troubleshoot process issues, conduct root cause analysis, and implement effective corrective actions.
• Ensure manufacturing processes comply with cGMP, FDA, and other regulatory requirements.
• Collaborate with R&D, Quality Assurance, and Manufacturing to ensure seamless technology transfer.
• Develop and implement process control strategies and monitor process performance.
• Author technical reports, documentation, and contribute to regulatory filings.
• Lead continuous improvement initiatives to enhance process efficiency, yield, and quality.
• Stay abreast of new technologies and industry trends in pharmaceutical manufacturing.
• Mentor junior engineers and provide technical guidance.

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or a related field.
• Minimum of 7 years of experience in pharmaceutical process development and manufacturing.
• Extensive knowledge of cGMP regulations and guidelines.
• Proven experience with process validation, scale-up, and technology transfer.
• Expertise in specific areas such as sterile manufacturing, lyophilization, or fill-finish operations is highly desirable.
• Strong understanding of Quality by Design (QbD) principles.
• Excellent analytical, problem-solving, and critical thinking skills.
• Proficiency in statistical analysis and process modeling software.
• Exceptional written and verbal communication skills.
• Ability to lead and work effectively in cross-functional teams.

• Leading the design, development, and optimization of pharmaceutical manufacturing processes, including formulation, filling, and packaging.
• Developing and executing process validation strategies in compliance with FDA and other regulatory requirements.
• Troubleshooting and resolving complex process-related issues in a timely and effective manner.
• Collaborating with R&D, Quality Assurance, and Manufacturing teams to ensure seamless technology transfer and scale-up.
• Implementing continuous improvement initiatives to enhance process efficiency, reduce costs, and improve product quality.
• Mentoring and guiding junior process engineers and technical staff.
• Preparing detailed process documentation, including SOPs, batch records, and validation reports.
• Staying current with industry best practices, new technologies, and regulatory changes in pharmaceutical manufacturing.
• Conducting process hazard analyses and implementing necessary safety measures.
• Overseeing equipment selection, installation, and qualification for new process lines.

• Design, develop, and optimize pharmaceutical manufacturing processes for commercial and clinical products.
• Lead process scale-up activities from laboratory to pilot plant and commercial manufacturing.
• Develop and execute process validation protocols and reports.
• Troubleshoot manufacturing deviations and implement corrective and preventative actions (CAPAs).
• Ensure all processes comply with cGMP, FDA, and other relevant regulatory guidelines.
• Contribute to the design and qualification of new equipment and manufacturing facilities.
• Perform process risk assessments and implement mitigation strategies.
• Collaborate with cross-functional teams on technology transfer and new product introductions.
• Author technical documents, such as batch records, SOPs, and development reports.
• Stay current with industry best practices and emerging technologies in pharmaceutical manufacturing.

• Master's or Ph.D. in Chemical Engineering, Pharmaceutical Engineering, or a related field.
• 7+ years of experience in pharmaceutical process development and manufacturing.
• In-depth knowledge of relevant pharmaceutical manufacturing technologies (e.g., sterile injectables, API synthesis, solid dosage forms).
• Proven experience in process validation, scale-up, and technology transfer.
• Strong understanding of cGMP regulations and regulatory submission requirements.
• Excellent analytical, problem-solving, and project management skills.
• Proficiency in statistical process control (SPC) and design of experiments (DOE).
• Strong written and verbal communication skills.
• Ability to work effectively in a team-oriented environment.

• Lead the design, development, and optimization of pharmaceutical manufacturing processes for new and existing products.
• Oversee process validation activities, including protocol development, execution, and report generation in compliance with regulatory requirements.
• Troubleshoot complex manufacturing issues, identify root causes, and implement effective corrective and preventive actions (CAPAs).
• Collaborate with R&D to ensure successful technology transfer from laboratory scale to pilot and commercial manufacturing.
• Apply chemical engineering principles to improve process efficiency, yield, throughput, and reduce costs.
• Ensure all manufacturing processes comply with cGMP, FDA, and other relevant regulatory guidelines.
• Develop and maintain process documentation, including PFDs, P&IDs, batch records, and standard operating procedures (SOPs).
• Mentor and provide technical guidance to junior process engineers and manufacturing personnel.
• Evaluate and recommend new technologies and equipment for pharmaceutical manufacturing.
• Participate in cross-functional teams to support product development, lifecycle management, and quality initiatives.
• Conduct process hazard analyses (PHAs) and implement safety improvements.
• Contribute to the strategic planning of manufacturing capabilities and capacity.

• Ph.D. or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a closely related scientific/engineering discipline.
• Minimum of 10 years of progressive experience in pharmaceutical process engineering, with a strong focus on drug product manufacturing.
• In-depth knowledge of cGMP regulations and pharmaceutical industry best practices.
• Proven experience in process development, scale-up, validation, and troubleshooting of complex pharmaceutical processes.
• Proficiency in process simulation software and data analysis tools.
• Excellent understanding of unit operations relevant to pharmaceutical manufacturing (e.g., filtration, drying, granulation, sterile filling).
• Demonstrated leadership skills and experience mentoring technical staff.
• Exceptional analytical, problem-solving, and decision-making abilities.
• Strong written and verbal communication skills, with the ability to present technical information effectively to diverse audiences.
• Experience with biologics or small molecule API manufacturing is highly desirable.
• Ability to work effectively in a demanding, highly regulated environment.

• Design, develop, and optimize pharmaceutical manufacturing processes.
• Conduct process validation studies and ensure compliance with GMP regulations.
• Implement and maintain robust process control strategies.
• Lead efforts to improve process efficiency, yield, and product quality.
• Collaborate with cross-functional teams for technology transfer and scale-up.
• Perform risk assessments and root cause analysis for manufacturing deviations.
• Implement corrective and preventative actions (CAPA).
• Stay current with pharmaceutical manufacturing technologies and regulatory requirements.
• Mentor and guide junior process engineers.
• Prepare technical reports and documentation.

• Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering, or a related field; Master's degree preferred.
• 5-7 years of experience in pharmaceutical process development and manufacturing.
• Strong understanding of GMP, FDA regulations, and ICH guidelines.
• Proven experience in process validation, scale-up, and technology transfer.
• Expertise in analytical techniques and process instrumentation.
• Excellent problem-solving, analytical, and project management skills.
• Strong communication and interpersonal skills, with the ability to collaborate effectively.
• Familiarity with continuous manufacturing technologies is a plus.

• Lead the design, development, and optimization of chemical processes for pharmaceutical drug substance and drug product manufacturing.
• Oversee process scale-up activities, ensuring successful technology transfer from laboratory to commercial production.
• Develop and execute process validation strategies in compliance with regulatory requirements (e.g., FDA, EMA).
• Conduct in-depth process investigations, root cause analyses, and implement corrective and preventive actions (CAPAs).
• Utilize process modeling and simulation tools to predict process performance and identify optimization opportunities.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs.
• Ensure adherence to Good Manufacturing Practices (GMP) and other relevant industry standards.
• Evaluate and implement new technologies and equipment to improve manufacturing efficiency and product quality.
• Provide technical leadership and mentorship to a team of chemical engineers and technical staff.
• Prepare technical documentation, reports, and presentations for internal stakeholders and regulatory submissions.

• Master's or Ph.D. in Chemical Engineering or a closely related discipline.
• 10+ years of experience in chemical engineering, with a significant focus on pharmaceutical or biopharmaceutical manufacturing.
• Extensive knowledge of GMP regulations and validation principles (IQ/OQ/PQ).
• Proven experience in process scale-up, technology transfer, and troubleshooting complex manufacturing issues.
• Strong understanding of unit operations relevant to pharmaceutical production (e.g., crystallization, filtration, drying, fermentation).
• Proficiency with process simulation software and statistical analysis tools.
• Excellent leadership, communication, and interpersonal skills.
• Ability to manage multiple projects simultaneously and meet demanding deadlines.
• Experience working in a hybrid model, balancing remote work with on-site presence at our Chicago, Illinois, US facility.