Senior MSAT Engineer — Cleaning Validation

Regulatory Jobs; Wilson (NC); On-site; USD 79,000 - 120,000; Full time

Job summary

Johnson & Johnson is seeking an Experienced Engineer, Process Engineering to join the Manufacturing Science and Technology team in Wilson, NC. The role focuses on MSAT Cleaning Validation, development and qualification activities, and cross-functional collaboration to support biologics manufacturing.

Ideal candidates bring 3+ years in pharmaceutical manufacturing, strong regulatory knowledge, and the ability to lead MSAT projects, with proficiency in MS Office and SAP.

Qualifications

• Degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field.
• Excellent verbal and written communication skills with internal and external customers.
• Excellent computer proficiency e.g. MS Office, Excel, SAP.
• At least 3 yrs experience in the pharmaceutical manufacturing industry or equivalent.
• Ability to work independently with minimum supervision to meet tight deadlines.
• Experience in biological Cleaning Validation (Minimum 2 years).
• Knowledge of FDA/EMEA regulations and project validation activities.
• Ability to lead multi-functional teams and manage complexity.
• Prioritize MSAT activities in line with schedules.

Responsibilities

• Conduct MSAT activities in compliance with US and EU regulations, local and global procedures and EHS&S requirements.
• Primary activities are in the Cleaning Validation area; perform cycle development, PQs, Clean Hold, and re-qualification.
• Develop MSAT documentation (protocols, procedures, reports) and coordinate document reviews and approvals.
• Review and approve documents prepared by other MSAT colleagues.
• Field execution of MSAT protocols.
• Liaise with Manufacturing to provide support for routine operations or projects.
• Compile information from contractors, suppliers, and other departments for technical reports.
• Track and resolve exceptions/events/nonconformances during MSAT activities.
• Prioritize MSAT activities in line with Manufacturing/project schedules.
• Coordinate MSAT activities with contractors and vendors as required.
• Attend training to fulfill Senior MSAT Engineer role requirements.
• Participate in multi-functional teams (project, investigations).

Skills

Communication skills

MS Excel

SAP

Independent worker

Regulatory knowledge

Education

Life sciences/engineering degree

Tools

MS Office

Job description

Johnson & Johnson is seeking an Experienced Engineer, Process Engineering to join the Manufacturing Science and Technology team in Wilson, NC. The role focuses on MSAT Cleaning Validation, development and qualification activities, and cross-functional collaboration to support biologics manufacturing.

Ideal candidates bring 3+ years in pharmaceutical manufacturing, strong regulatory knowledge, and the ability to lead MSAT projects, with proficiency in MS Office and SAP.