Associate 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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Professional

All Job Posting Locations:

Wilson, North Carolina, United States of America

Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

We are searching for the best talent for anAssociate Manufacturing Process Specialist (Entry-level)to be based inWilson, NC.

Role Summary

TheManufacturing Process Specialistis a technical expert supporting the manufacturing of biological products both on the site and across the network. Provides technical expertise to ensure that atypical event and non-conformance investigations relating to production and the testing of materials and products are completed in compliance with all applicable procedures and regulations. Monitors and trends key process parameters. Troubleshoots manufacturing problems as required and provide primary technical support. Identifies and implement process improvements both locally and across the network. Supports capital projects, site wide initiatives or other projects as needed in the capacity of a project manager or a subject matter expert. Conducts technical and validation studies. This position requires strong organizational, communication and project management skills.

Key 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 a number of the following areas: 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.

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.
• Experience in one or more area of bioprocess expertise of Protein purification, Ultrafiltration, Virus Filtration, Media and/or buffer preparation.
• Experience in Cleaning and Sterilization validation, preferred
• Experience of Autoclaves and Sterilization, preferred
• Working knowledge of cGMP's in a biopharmaceutical or pharmaceutical manufacturing environment is preferred.
• The ability to apply basic project management skills to complete assigned projects effectively and consistently to meet challenging schedules is required.
• Influencing skills, partnering and collaboration skills, analytical skills and good oral and written presentation skills are required, with a demonstrated ability to work across organizational boundaries.
• Strong interpersonal skills to build productive relationships, collaborate effectively, and work well within a team while treating others with dignity and respect.
• Flexibility and adaptability in a dynamic supply chain environment, with the ability to act quickly and with accountability to meet organizational goals.
• Cultural sensitivity and ability to thrive in a multi-cultural and matrixed environment.
• Knowledge of FDA/EMEA regulatory requirements related to biologics and/or pharmaceuticals, preferred.
• Maintain high ethical standards and integrity through Credo-based actions.

Other Requirements

This position will be designated for daytime work during project phase, though off-shift work may be required routinely. On Call support may be required on a rotational basis. Must be available for other duties as required.

During commercial phase, this position will be designated for off-hours (night) shift.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Onsite

Required Skills:

Required Skills:

Preferred Skills:

Agile Manufacturing, Analytical Reasoning, Analytics Dashboards, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Data Analysis, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Manufacturing Standards, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Technical Credibility

Required Skills:

Required Skills:

Preferred Skills:

Agile Manufacturing, Analytical Reasoning, Analytics Dashboards, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Data Analysis, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Manufacturing Standards, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Technical Credibility