Experienced Engineer Process Engineering- Thermal Validation

Johnson & Johnson • Wilson, NC

8h • $79,000 - $120,000 • Onsite

About The Position

Johnson & Johnson is seeking an Experienced Engineer - Thermal to join their Manufacturing Science and Technology (MSAT) team in Wilson, North Carolina. This role is part of a significant supply chain investment to expand manufacturing capacity for biotherapeutics, supporting portfolio growth and delivering breakthrough medicines. The MSAT team manages the process technology platform strategy, including Process & Cleaning Validation, Equipment Standardization, and Life Cycle Management for commercial production processes.

Requirements

• Degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field.
• Excellent verbal and written communication skills.
• Excellent computer proficiency (e.g., MS Office, Excel, SAP).
• At least 3 years of experience in the pharmaceutical manufacturing industry or equivalent.
• Ability to work independently with minimum supervision to meet tight deadlines.
• Minimum 2 years of experience in biological Thermal Validation.
• Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.
• Ability to work independently under general direction, with good prioritization and time management skills.
• Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

Nice To Haves

• Experience in Projects.
• Experience in Process Validation Support (e.g., Mixing Studies, Microbial Hold Studies, Media Challenges).
• Experience in Cleaning Validation.
• Experience supporting process improvement projects.
• Experience supporting New product Introduction/process validation.
• Ability to lead multi-functional teams and to manage complexity and change.

Responsibilities

• Conduct MSAT activities in compliance with US and EU regulations, JBI procedures and EHS&S requirements, primarily in the Thermal Validation area.
• Perform autoclave Cycle Development, Performance Qualifications, and Controlled Temperature Equipment (refrigerators/freezers) and Re-Qualification executions.
• Develop MSAT documentation (e.g., strategies, plans, protocols, procedures, reports) and coordinate MSAT document review and approval.
• Review and approve documents prepared by other MSAT colleagues.
• Execute MSAT protocols in the field.
• Liaise with Manufacturing to provide support for routine operations and project-based work.
• Compile relevant information from contractors, suppliers, and other departments to develop technical reports.
• Represent the JBI MSAT site team on platform technical teams.
• Prepare reports for completed protocols for review and approval.
• Initiate and implement change control activities in accordance with site procedures.
• Track and resolve exceptions/events/nonconformances during MSAT activities.
• Prioritize MSAT activities in line with Manufacturing or project schedules.
• Coordinate MSAT activities with contractors and vendors.
• Attend identified training required for the role.
• Participate in multi-functional teams (project, investigations) as required.
• Provide support for Process Validation (e.g., Mixing Studies, Microbial Hold Studies, Media Challenges), Cleaning Validation, process improvement projects, New Product Introduction/process validation, and GMP documentation generation (e.g., protocols/SOPs/WIs/Technical Documents, Exception/Event Investigations).

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year (or 56 hours in Washington State)
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member, 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours

What This Job Offers

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