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
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:
Johnson & Johnson is currently seeking a Manufacturing Process Specialist to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina .
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine.
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
The Manufacturing Process Specialist is a technical expert supporting the manufacturing and distribution 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, distribution, 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, and distribution 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 optimization and revalidation efforts.
Serves as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA, EMEA).
Maintains various databases of production and distribution information:
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, biotherapeutics manufacturing, sampling of raw materials, weigh & dispense of raw materials, kitting, and drug substance shipping, and 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.
Create and or provide documentation support for SOPs, WIs, 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
Key Business Result:
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
Qualifications - External
Required:
B.S. degree, with at least 6+ years of experience in a manufacturing or distribution 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 in biotherapeutics manufacturing, sampling of raw materials, weigh & dispense of raw materials, kitting, drug substance shipping, pharmaceutical water systems and utilities, and media or buffer preparation.
Working knowledge of cGMP's in a biopharmaceutical manufacturing or pharmaceutical distribution 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.
Preferred:
Experience of Microsoft Word, Excel, PowerPoint, and Outlook.
Experience of DCS (e.g Delta V), MES, SCADA and PLC systems.
Experience of SAP or other business systems.
This job posting is anticipated to close on 08/22/2025 . The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Employees are eligible for the following time off benefits:
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
Additional information can be found through the link below. For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
