Johnson & Johnson · 9 hours ago
Sr Process Engineering- MSAT
Wilson, NC
Full-time
Onsite
Senior Level
7+ years expJohnson & Johnson is a leader in healthcare innovation, focusing on developing treatments and cures for complex diseases. They are seeking a Senior Process Engineer to join their Manufacturing Science and Technology (MSAT) team in Wilson, NC, where the role involves managing process technology strategies and ensuring compliance with manufacturing standards.
Hospital & Health Care
Responsibilities
Active engagement with the MSAT team, delivering a successful outcome to MSAT Tech transfer activities and Process Analytics implementation using Good Manufacturing Practices (GMP)
Primary activities are in the Tech transfer of new/commercial products as well as implementation of new technologies and/or digital tools. Planning, documenting, and performing process validation studies
Coordinate and execute MSAT process lifecycle management activities for new equipment, processes, and site startup initiatives in compliance with US and EU regulations and company procedures
Coordinate and execute process improvement projects, commercial product scale-up initiatives, and technical transfer activities ensuring a successful implementation
Apply technical expertise to offer second-line support to our Manufacturing Operations team as well as provide technical guidance for process improvement projects and investigations
Track and resolve exceptions/events/nonconformances during MSAT activities
Coordinate and prioritize MSAT activities in alignment with the applicable manufacturing and project schedules
Implement, qualify, and maintain PAT tools (e.g., Raman spectroscopy, capacitance probes, soft sensors) to enable real‑time monitoring of upstream and downstream CQAs and CPPs
Integrate PAT instrumentation with manufacturing data systems to support process control, process robustness, and continuous verification as well as analyze process data to identify trends, deviations, and sources of variability across biologics manufacturing operations
Conduct statistical modeling, multivariate analysis (e.g. PCA/PLS), and batch trajectory analytics to support investigations, CPV, continuous improvement initiatives and detect early signals of process drift
Support model lifecycle activities including development, validation, documentation, and ongoing performance monitoring in a GMP environment
Able to author basic modeling-related documents (e.g., model development reports, analysis summaries)
Prepare, review, and approve technical documents, CAPAs, change control requests, investigations, protocols, reports, and SOPs, as needed
Compile relevant information from contractors, suppliers, and other departments to develop technical reports
Attend identified training required to fulfill the role of a Tech Transfer Engineer
Participate in multi-functional teams (project, investigations) as required
Qualification
Required
A minimum bachelor's degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field, required
A minimum of 7 years of experience in the pharmaceutical manufacturing industry or regulated industry experience or 4+ years with advanced degree (MS/MBA/Ph.D or equivalent)
A minimum 2 years of experience in Technical Transfer process
Experience with process analytics, modeling
Proven knowledge and application of industry regulations including those of FDA, EMEA, and other authorities
Ability to collect, process, and analyze data to draw meaningful conclusions and make informed decisions for studies
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
Excellent computer proficiency e.g MS Office, Excel, SAP
Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests
Adaptable and flexible with great problem-solving skills
Ability to work independently with minimum supervision, having a good sense of prioritization of goals and good time management
Preferred
Supporting New Product Introduction/ process validation
Ability to lead multi-functional teams and to manage complexity and change
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase