Senior Process Engineer, MSAT External Manufacturing

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com.

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.

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Process Improvement

Job Category:

People Leader

All Job Posting Locations:

Athens, Georgia, United States of America

Job Description:

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 https://www.jnj.com/innovative-medicine.

We 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 pre–tech 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

• Bachelor’s 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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills:

Agile Manufacturing, Business Valuations, Chemistry, Manufacturing, and Control (CMC), Consulting, Controls Compliance, Developing Others, Good Automated Manufacturing Practice (GAMP), Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Plant Operations, Process Control, Process Improvements, Quality Management Systems (QMS), Quality Standards, Quality Systems Documentation, Standard Operating Procedure (SOP), Team Management, Time Management