Process Engineering- Process Validation Support

Johnson & Johnson • Wilson, NC

9h • $79,000 - $120,000 • Onsite

About The Position

Johnson & Johnson is seeking an Experienced Engineer- Process Validation Support (PVS) to join their Manufacturing Science and Technology team in Wilson, North Carolina. This role is part of a significant supply chain investment to expand manufacturing capacity for innovative biologic medicines, including oncology, immunology, and neuroscience. The Manufacturing Science and Technology (MSAT) department manages the process technology platform strategy for biotherapeutics production, focusing on Process & Cleaning Validation, Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of commercial production processes.

Requirements

• Degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field is required.
• 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.
• At least 3 yrs experience in the pharmaceutical manufacturing industry or equivalent.
• Must be able to work independently with minimum supervision to meet tight deadlines.
• Experience in biological Process Validation (Minimum 2 years).
• Attention to detail, excellent communication skills, both written and verbal.
• Supporting New Product Introduction/ process validation.
• Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.
• Ability to work independently under general direction, having a good sense of prioritization of goals and good time management.
• Adaptable and flexible with great problem-solving skills.
• Ability to lead multi-functional team and to manage complexity and change.
• Proven knowledge and application of industry regulations including those of FDA, EMEA, and other authorities.

Nice To Haves

• Analytical Reasoning
• Computerized Equipment Skills
• Emerging Technologies
• Gemba Kaizen
• Issue Escalation
• Lean Supply Chain Management
• Problem Solving
• Process Control
• Process Engineering
• Process Oriented
• Product Improvements
• Science, Technology, Engineering, and Math (STEM) Application
• Situational Awareness
• Supply Planning
• Technical Research
• Technologically Savvy
• Validation Testing

Responsibilities

• Conduct MSAT activities in compliance with US and EU regulations, local and global procedures and EHS&S requirements.
• Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges, In-Line Conditioning Verification Studies, Chemical Hold Studies) area.
• Leading and/or providing technical guidance for process improvement projects and investigations.
• Develop MSAT documentation (e.g. protocols, procedures, reports) and co-ordinate MSAT document review and approval.
• Review and approve documents prepared by other MSAT colleagues.
• Field execution of MSAT protocols.
• Liaise with Manufacturing to provide support where required with routine operations / project-based work.
• Compile relevant information from contractors, suppliers, and other departments to develop technical reports.
• Track and resolve exceptions/events/nonconformances during MSAT activities.
• Prioritize MSAT activities in line with Manufacturing / the project schedule.
• Co-ordinate MSAT activities with contractors and vendors as required.
• Attend identified training, required to fulfill the role of an experienced MSAT Engineer.
• Participate in multi-functional teams (project, investigations) as required.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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: Mid Level