Entry-Level Biopharma Manufacturing Process Specialist

Biopharma Careers; Kansas; On-site; USD 55,000 - 75,000; Full time

Job summary

Johnson & Johnson is seeking an Associate Manufacturing Process Specialist (Entry-level) to support the manufacturing of biological products at the Wilson, NC site. You will provide technical floor support, investigate deviations, and help implement corrective actions to ensure product quality and compliance.

The role requires a B.S. degree with 0–2 years of manufacturing experience, strong problem-solving skills, and the ability to work cross-functionally in a regulated biopharmaceutical

Qualifications

• B.S. degree, with 0-2 years of experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry experience, or an equivalent combination of education and experience or equivalent military experience.

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. Approve investigations as management technical representative, as needed.
• Recommends, owns and implements corrective/preventative measures aimed at improving compliance and reducing repeat occurrences. Follow up to determine if corrective actions adequately addressed root cause of event.
• Collaborates with management to review and approve events and deviations.
• Tracks deviations, events and key process parameters and provide reports to management on trending, and status as requested. Recommends corrective actions for any trends identified.
• Act 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. Implement process improvements within the change control system.
• Recognizes and acts on potential compliance issues and opportunities for process changes/improvement.
• Work with management to allocate group resources to assist with change control, equipment startup, and technical training. Assure regulatory compliance and technical feasibility of proposed changes.
• Develops business cases for projects and present to site leadership for approval. Initiate and execute change controls for projects. Assist with equipment startup and technical training as required.
• Serves as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
• Shares best practices between production sites.
• Provides technical support for process and cleaning validation maintenance and verification. Assist with cleaning cycle optimization and revalidation efforts.
• Serves as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA, EMEA).
• Maintains various databases of production information:
• Extract process data from SCADA and Delta-V servers for use in databases maintained by technical operations.
• Use databases to monitor process performance and proactively troubleshoot operations. Work with Automation and Information Management to improve the effectiveness of process data collection and analysis.
• Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).
• Demonstrates expertise in cGMPs, FDA regulations, cell banking, formulations, Cell culture, chromatographic purification, ultrafiltration, microfiltration, diafiltration, viral inactivation, filter integrity testing, CIP/SIP systems, or pharmaceutical water systems and utilities.
• Provide documentation support for SOP/WIs/ Batch Record revisions.
• Identify necessary document changes and provide to document management group to ensure timely revision to all SOP and batch records.
• Review and approve SOP and Batch record revisions.
• Is responsible for the training of new staff members.
• Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA. Complies with all company and site policies and procedure.

Skills

Biopharma manufacturing

cGMP

Project management

Analytical reasoning

Interpersonal skills

Process troubleshooting

Education

B.S. degree

Job description

Johnson & Johnson is seeking an Associate Manufacturing Process Specialist (Entry-level) to support the manufacturing of biological products at the Wilson, NC site. You will provide technical floor support, investigate deviations, and help implement corrective actions to ensure product quality and compliance.

The role requires a B.S. degree with 0–2 years of manufacturing experience, strong problem-solving skills, and the ability to work cross-functionally in a regulated biopharmaceutical