Pharmaceutical Senior Process Engineer

Global Edge Group is recruiting on behalf of a leading pharmaceutical manufacturer dedicated to developing, manufacturing, and supplying high-quality medicines that improve patient health and well-being worldwide. Our client operates a diverse portfolio of pharmaceutical products and manufacturing operations, supporting patients, healthcare providers, and healthcare systems through innovative and reliable solutions.

We are seeking a talented and motivated Senior Process Engineer, Third-Party & Technical Services to join a dynamic technical operations team.

The Senior Process Engineer will lead process validation, product registration support, and technology transfer activities for both internally manufactured and third-party contract manufacturing (CMO) products. This role ensures alignment with quality, regulatory, and commercialization objectives while supporting multiple dosage forms throughout the product lifecycle.

The successful candidate will serve as a technical expert responsible for process development, scale-up, validation, commercialization, and continuous process improvement while collaborating closely with manufacturing, quality, regulatory, development, and external partners.

• Serve as a process and formulation subject matter expert for cGMP and FDA requirements, supporting process registration, scale-up, validation, and commercial manufacturing activities for internal and third-party products.
• Lead process development, transfer, and validation efforts for pharmaceutical products across various dosage forms.
• Act as the technical services representative for manufacturing process flow, equipment requirements, and technical assessments during project selection and execution.
• Conduct and lead technical evaluations and site visits at contract manufacturing organizations (CMOs).
• Drive gap assessments, risk assessments, and statistical analyses related to process design, scale-up, validation, and continuous improvement initiatives, including Process Analytical Technology (PAT) and Design of Experiments (DOE).
• Develop validation and filing strategies, including batch sizing, sampling plans, protocol development, and execution requirements.
• Create, review, and approve manufacturing documentation, including:
• Master Manufacturing Records
• Batch Records
• Validation Protocols and Reports
• Technical Justifications
• Process Documentation
• Provide technical expertise during registration, scale-up, process transfer, validation, and commercial manufacturing campaigns at internal and external manufacturing sites.

• Collaborate with Product Development and project teams to establish robust control strategies for commercial manufacturing.
• Support regulatory submissions including ANDAs, NDAs, PAS submissions, response packages, and related technical documentation.
• Partner with Regulatory Affairs to author and/or review filing documentation and support regulatory approvals.
• Contribute to Quality by Design (QbD) documentation and process development reporting.
• Evaluate registration-scale batch data and support equipment procurement or modification activities required for commercial production.

• Lead planning and execution of:
• Process Scale-Up
• Technology Transfer
• Process Validation / PPQ
• Commercial Production
• Continued Process Verification (CPV)
• Serve as the primary process validation lead throughout the product lifecycle.
• Develop manufacturing strategies related to validation lots, commercial batch sizing, and launch readiness.
• Support ongoing lifecycle management, CPV programs, and revalidation activities.

• Lead complex investigations related to process deviations, non-conformances, and manufacturing issues.
• Conduct root cause analyses and implement corrective and preventive actions (CAPA).
• Collaborate with Quality, Regulatory, Manufacturing, and Engineering teams to implement process changes and continuous improvement initiatives.
• Lead optimization efforts involving:
• Raw material changes
• API changes
• Process parameter modifications
• Batch size optimization
• Equipment enhancements
• Drive resolution of process quality and product stability issues in commercial products.

• Mentor junior engineers and technical staff in process engineering, validation strategies, investigations, CAPA development, and manufacturing technologies.
• Promote knowledge sharing and adoption of best…