Johnson & Johnson is currently seeking a Manufacturing Process Specialist to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

• 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 procedures.
• 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
• This position may require international travel for extended periods for training

• Customer Service Levels / OTS / OTD / OTIF / LIFR
• Inventory KPIs
• Quality - Critical Observations / Field Escalations / CAPA Closure
• Cost Improvement plans
• EHS&S - Good Saves, Significant Good Saves, Lost Working Days

• 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 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.

• Experience of Microsoft Word Excel and Outlook.
• Experience of DCS (e.g Delta V), SCADA and PLC systems.
• Experience of SAP or other business systems.

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of 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