Manufacturing Process Specialist (multiple openings)

Johnson & Johnson • Wilson, NC

387d

About The Position

The Manufacturing Process Specialist at Johnson & Johnson will play a crucial role in supporting the manufacturing of biological products. This position involves providing technical expertise during the project design and construction phases, as well as ongoing operational support. The specialist will be responsible for troubleshooting manufacturing issues, ensuring compliance with regulations, and implementing process improvements to enhance production efficiency and product quality.

Requirements

• B.S. degree with at least 6+ years of experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry experience, or an equivalent combination of education and experience.
• Experience in one or more area of bioprocess expertise of Protein purification, Ultrafiltration, Virus Filtration, Media and/or buffer preparation.
• Working knowledge of cGMP's in a biopharmaceutical or pharmaceutical manufacturing environment is preferred.
• Ability to apply basic project management skills to complete assigned projects effectively and consistently to meet challenging schedules.
• Strong interpersonal skills to build productive relationships and collaborate effectively within a team.

Nice To Haves

• Experience in Cleaning and Sterilization validation.
• Experience of Autoclaves and Sterilization.
• Knowledge of FDA/EMEA regulatory requirements related to biologics and/or pharmaceuticals.
• Experience of Microsoft Word, Excel, and Outlook.
• Experience of DCS (e.g Delta V), SCADA and PLC systems.

Responsibilities

• Provides primary (on floor) production support for the resolution of technical issues, process improvement initiatives and business reliability.
• Provides technical support for the investigation and resolution of deviations and atypical events.
• Partners with primary investigator to ensure consistent quality standards are maintained.
• Provides technical expertise to help identify true root cause of investigations and assess product quality impact.
• Recommends, owns and implements corrective/preventative measures aimed at improving compliance and reducing repeat occurrences.
• Collaborates with management to review and approve events and deviations.
• Tracks deviations, events and key process parameters and provides reports to management on trending, and status as requested.
• Acts as subject matter expert (SME) to customers, providing guidance on deviations, investigations, and issues pertaining to quality of product.
• Identifies and implements process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
• Develops business cases for projects and presents to site leadership for approval.
• Serves as project manager for the change process and provides coordination to ensure timely and compliant implementation of process improvements.
• Provides technical support for process and cleaning validation maintenance and verification.
• Maintains various databases of production information and monitors process performance.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• 401(k) retirement plan and savings plan.
• Long-term incentive program participation.
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees in Washington - up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree