The Process Engineer III has responsibility for the planning and execution of all technical aspects of product and/or process technology transfer to the site through successful completion of PPQ. This includes feasibility evaluations, design, execution, and documentation of engineering studies, component specification and evaluation, and all other activities required to support delivery of a complete, validated process to manufacturing. Individuals in this role work closely with Validation, PMO, Supply Chain, Operations, Quality, and technical experts performing transfers to the site to ensure process implementation to commercial manufacturing follows project timelines and corporate standards.

• Key responsibilities

  • Provide primary site technical support for the entire Tech Transfer process from initial evaluation to PPQ, including change control ownership, in compliance with site procedures.

  • Define and own technical requirements for new equipment design specifications (URS)

  • Develop and own site Control Strategy Documents for processes transferred

  • Work with Project Managers to ensure proper planning of MSAT activities to meet timelines.

  • Communicate priorities and progress to team on a continuing basis.

  • Develop and execute development studies in support of new equipment, products, and processes.

  • Make detailed observations, analyze data, and interpret results.

  • Ensure proper documentation of activities, actions, and/or results.

  • Create documents required for new process execution in Operations, including SOPs, Batch Records, Specifications, Initial and ongoing Validation requirements, etc.

  • Ensure that Operations has all tools needed to execute new processes in an efficient manner.

  • At the point of process transfer to Operations (PPQ), assure validated state of the process and clear definition and documentation of controls required to maintain validated state.

  • Provide leadership, development, and mentoring of Operations colleagues during Tech Transfer and qualification activities.

  • Provide support for regulatory inspections as technical process owner

  • Coordinate the activities of external resources as required

  • Effectively present technical data in an understandable fashion to support decision making.

  • Maintain a high level of expertise through review of relevant scientific literature and guidelines

  • Perform work requirements in a responsible manner in accordance with SOPs, cGMPs and safety procedures in accordance with OSHA requirements and company SHE guidelines.

  • Contribute to the development of group and site culture by exercising creativity in dealing with new problems encountered within an evolving organization.

  • Take an active role in finding solutions and improvements for the facility as a whole.

  • Work with minimal supervision under the direction of the MS&T Technical Lead.

  • Maintain classified area gowning certifications to support assigned tasks, as required.

Minimum Qualifications

• Proven ability to work effectively in a team environment

• Ability to generate and interpret technical documents

• Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.

• Ability to lift and handle equipment and materials associated with engineering study execution.

• Willingness and ability to maintain aseptic gowning certification as established by company procedures

• Preferred Qualifications

• • Bachelor’s degree or 2-year technical degree with equivalent experience

  • At least 5 years of experience in process development, tech transfer, or engineering, with at least 3 years in pharmaceuticals or a similar regulated industry.

  • 4-year degree in a technical discipline

  • Prior experience in Tech Transfer in the pharmaceutical industry, including formulation, sterile filtration, aseptic filling, automated visual inspection, and/or packaging and labeling.

  • Previous experience with automated equipment, including recipe creation and process control logic

  • Experience with OEE, TPM, LEAN or other Continuous Improvement systems

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