Senior Plant Hygienist Job at Kenvue
Kenvue is currently recruiting for a Senior Plant Hygienist. This position reports into Sr Director NA MAKE Q and Co and is based at Fort Washington, PA.
Who We Are
At Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.
Join us in shaping our future-and yours.
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The Sr. Plant Hygienist will provide support the US Self-Care organization; including the four (4) manufacturing sites located in Guelph, Lititz, Las Piedras, and Fort Washington and Self-Care External Manufacturing Quality Assurance organization. Under limited supervision, leads and support strategic microbiological programs and compliance. Responsible for providing microbiological technical compliance support, internal and external audit support, inspection readiness, and critical investigations. The Senior Plant Hygienist is accountable for providing leadership to and guiding the Quality Assurance, Engineering, MS&T, related to hygienic equipment design, operating practices, cleaning, and sanitization to ensure robust microbiological contamination control.
The Sr. Plant Hygienist, Responsibilities
- Train personnel on microbiological compliance
- Provide technical expertise to colleagues regarding the interpretation and/or implementation of cGMP hygienic practices.
- Assure hygienic systems, from raw material sampling, pre-weigh, compounding, packaging, and microbiological testing are following the J&J and industry expectations and are correctly, implemented and controlled.
- Provide technical support to US Self-Care Microbiology laboratories and serve as the expert on matters related to laboratory test standards, compendia requirements cGMP, and microbiological methods.
- Establish Standard Operating Procedure (SOPs) to reduce microbiological risk within the test laboratory and production environment’ provide review or approval of SOPs as assigned.
- Conduct hygienic practice reviews of the test laboratory and production environment.
- Troubleshoot equipment and methodologies communicate microbiological risk to appropriate technical and quality individuals.
- Review and approve laboratory reports, trend analysis.
- Support Quality Management review and provide the compliance of the site as requested.
- Provide technical support to the new product introduction process, including review of raw material and finished product microbiological risk classification, equipment train readiness, cleaning and sanitization practices, and remedial action plan development.
- Approve microbiological test method and specifications, and specification change requests as needed.
- Review and approve validation approaches/protocols and reports ensuring compliance to regulatory and company requirements as needed.
- Maintain knowledge of regulatory environment, cGMPs, FDA polices and current industry trends. Interface with internal and external auditing groups and global regulatory agencies to discuss hygienic practices for site inspections.
- Provide direction and leadership to assure compliance with quality, environmental and safety regulations as well as company policies.
- Participate on regional and global project teams with peers.
- Collaborate with operations and R&D in quality, productivity improvement and cost reduction.
- Collaborate with Procurement, External manufacturing quality assurance, travel to and consult with third party manufacturers to assess their hygienic readiness to produce product for J&J.
- Support off-shift operations and trainings opportunities.
- Perform other duties as assigned.
- Evaluate and recommend new microbiological technology to improve quality, efficiency, cost effectiveness, safety, and reduce environmental footprint of analysis.
- Strongly collaborates with R&D, R&D Compliance, Site Quality Control Units and Quality product support groups.
- Obtain feedback and comments on methods being utilized at the sites to assure accuracy and usability.
- Participate as contributor on regional teams to develop and deploy new policies, procedures, and technology.
- Participate as contributor on Pharmacopeia Forum to provide feedback and direction.
A minimum of a Bachelor of Science Degree, preferably Microbiology, or Biological Science with an emphasis in Microbiology
- Minimum of 10+ years of work-related experience, including: Broad-based experience, or combination oof experience, in cosmetic/pharmaceutical manufacturing, facility/utility engineering, microbiology laboratory operations, quality operations, and regulatory compliance.
- Significant knowledge of microbial quality assurance is required.
- Operations in the OTC and/or pharmaceutical manufacturing and/or medical devices industries
- Minimum 3 years of direct experience in a management role
- Knowledge of production and manufacturing operations
- Front room experience working with regulatory agencies
- Thorough knowledge of cGMPs and regulatory requirements/guidance are required
- Experience in leading and executing non-conformance investigations.
- Batch record review experience
- Experience leading cGMP compliance audits of Manufacturing and Packaging
- Previous line/people management experience is required.
Preferred Requirements
- A non-sterile OTC or pharmaceutical industry is preferred.
- Experience in employee supervision is preferred.
What’s in it for you
- Competitive Benefit Package
- Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
- Learning & Development Opportunities
- Employee Resource Groups
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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