Associate MPS (Entry-Level)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere 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 are searching for the best talent for an Associate Manufacturing Process Specialist (Entry-level) to be based in Wilson NC.

Role Summary

TheManufacturing Process Specialistis a technical expert supporting the manufacturing of biological products both on the site and across the 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 and trends key process parameters. Troubleshoots manufacturing problems as required and provide primary technical and implement process improvements both locally and across the capital projects site wide initiatives or other projects as needed in the capacity of a project manager or a subject matter technical and validation 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 investigations as management technical representative as needed.

• Recommends owns and implements corrective/preventative measures aimed at improving compliance and reducing repeat 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 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 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 regulatory compliance and technical feasibility of proposed changes.

• Develops business cases for projects and present to site leadership for and execute change controls for 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 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 cGMPs 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 Call support may be required on a rotational 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 Internal employees contact AskGS to be directed to your accommodation resource.

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