Senior Process Engineer, MSAT External Manufacturing

Johnson & Johnson Innovative Medicine • Athens, GA

2d • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Inclusive work environment where each person is considered as an individual.
• Respect for the diversity and dignity of employees and recognition of their merit.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior