Senior Process Engineer, MSAT External Manufacturing

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are looking for the best talent for Senior Process Engineer in Athens Georgia.

The Senior Process Engineer MSAT External Manufacturing (EM) is responsible for providing technical leadership and process support for the manufacture of intermediates and Active Pharmaceutical Ingredients (API) at external manufacturing sites. This role monitors process performance and drives improvements in cycle time yield quality and operational efficiency. The position also supports the introduction and validation of new and existing products resolves sophisticated manufacturing challenges and provides technical expertise during regulatory inspections and other compliance-related activities.

Key Responsibilities:

• Support lifecycle management activities for external sites including technical assessments onboarding due diligence fit-for-purpose evaluations and ongoing engagement with CMOs aligned to MSAT product strategies and innovation initiatives.

• Coordinate pretech transfer readiness with multi-functional partners (TLI R&D GET EMST) to support clinical manufacturing primary transfers and selected secondary or post-TOO transfers.

• Support technology transfer activities including strategy development product introduction assessments characterization studies PPQ execution data analysis with SMEs and implementation of technical evaluations and change controls.

• Support product lifecycle management activities including CPV programs criticality analysis and APR/APQR reviews to maintain technical performance and compliance.

• Contribute to process excellence and continuous improvement through cleaning validation shipment qualification process optimization and updates to SOPs batch records and change controls in collaboration with GET EHS EQ and SMEs.

• Maintain site lifecycle management documentation including account plans technical risk segmentation and proactive assessments such as cleaning validation and cross-contamination evaluations.

• Provide technical support for base business operations by contributing to complex investigations (e.g. deviations OOT/OOS complaints CAPAs) material changes qualifications supply continuity efforts and audit or inspection readiness.

• Support new product introductions and line extensions by partnering with TLI and R&D on tech transfers scale-up activities manufacturing plans and review of key technical documentation.

• Contribute to manufacturing process excellence through capability assessments de-risking activities and continuous improvements in cost yield cycle time capacity and technology.

• Support innovation and standardization by evaluating and implementing new technologies including PAT process modeling and data systems and by contributing to Technical Operations standardization initiatives.

• Perform related duties as assigned by supervisor

• Maintain compliance with all company policies and procedures.

Qualifications

EDUCATION

• Bachelors degree is required.

Experience and skills:

Required:

• Minimum of 4 years of proven experience in Manufacturing MSAT process science or technical operations within the pharmaceutical or related industry.

• Support external manufacturing partners (CMOs) across technology transfer lifecycle management and manufacturing operations.

• Apply strong knowledge of process science validation and lifecycle activities including CPV APR/APQR investigations and CAPA.

• Work independently and collaboratively to deliver results in cross-functional team environments.

• Contribute to technology transfers process improvements and manufacturing optimization initiatives.

• Lead or support complex nonconformance investigations using structured problem-solving and root cause analysis.

• Communicate clearly and collaborate effectively with collaborators across global cross-functional teams.

Preferred:

• Apply experience in process introduction optimization and scale-up to implement innovative technologies including automation and data-driven tools.

• Support regulatory readiness by contributing to audits inspections and interactions with health authorities.

• Drive or support global supply chain initiatives and large-scale technical transformation efforts.

• Bring training or certification in GMP Lean Six Sigma or related continuous improvement practices.

• Make informed decisions solve complex problems and prioritize effectively in a fast-changing environment.

• Influence outcomes and build alignment across teams without direct authority.

• Act with integrity and ensure decisions reflect Johnson & Johnson Credo values.

Other:

• Willingness to travel as needed (domestic and/or international) to support business needs.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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