Johnson & Johnson companies are equal opportunity employers.
Manager Plant Hygienist-4405140212
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Manager Plant Hygienist, located in Fort Washington or Lancaster, Pennsylvania.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB and SUDAFED® nasal decongestants.
The Manager Plant Hygienist is accountable for providing leadership to and guiding the Quality Assurance, engineering and production operation activities related to hygienic equipment design, operating practices, cleaning, and sanitization at both the Lancaster and Fort Washington Plants. The Plant Hygienist participates in the development of the organization’s hygienic implementation strategies, goals, and objectives in accordance with J&J standards to assure that all products produced at McNeil meet company and regulatory microbiological standards.
The Manager Plant Hygienist will 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 in compliance with the principles outlined in the J&J Code of Hygienic Practices and are correctly implemented and controlled. Establish Standard Operating Procedure (SOPs) to reduce microbiological risk within the test laboratory and production environment; provide review or approval of SOP’s as assigned. Conduct hygienic practice audits of the test laboratory and production environment. Troubleshoot equipment and methodologies; communicate microbiological risk to customers. Provide reports, trend analysis or feedback to inform management of quality trends and to establish corrective actions. Support Quality Management Review and provide the compliance of the site. Prepare and present numerous written and verbal reports indicating hygienic state of the facility including deviations, equipment design, corporate policy compliance and best practices. Support CAPA systems; lead investigation activities, provide effective corrective actions, provide review of reports associated with significant microbiological quality issues. Provide technical support to the new product introduction process, including review of raw material and finished product microbiological risk classifications, equipment train readiness, cleaning and sanitization practices, and remedial action plan development. Approve microbiological test method 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 policies 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, Contract Quality Assurance, travel to and consult with third party manufacturer’s to assess their hygienic readiness to produce product for J&J. Support off-shift operations and training opportunities. Perform other duties as assigned.
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A Bachelor of Science Degree is required. A degree in Microbiology, Biological or Science related with an emphasis in Microbiology is preferred. 10 years of related work experience including broad based experience or combination of experience in cosmetic/pharmaceutical manufacturing, facility/utility engineering, microbiology laboratory operations, quality operation and regulatory compliance is required. A significant knowledge of microbial quality assurance is required. A non-sterile OTC or pharmaceutical industry is preferred. Previous supervisory experience is preferred. A strong influencing skills in a cross-functional matrix environment is required.
This position could be located in either Fort Washington, PA or Lancaster, PA and will be required to travel 10% domestically.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Manager Plant Hygienist-4405140212
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Manager Plant Hygienist, located in Fort Washington or Lancaster, Pennsylvania.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB and SUDAFED® nasal decongestants.
The Manager Plant Hygienist is accountable for providing leadership to and guiding the Quality Assurance, engineering and production operation activities related to hygienic equipment design, operating practices, cleaning, and sanitization at both the Lancaster and Fort Washington Plants. The Plant Hygienist participates in the development of the organization’s hygienic implementation strategies, goals, and objectives in accordance with J&J standards to assure that all products produced at McNeil meet company and regulatory microbiological standards.
The Manager Plant Hygienist will 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 in compliance with the principles outlined in the J&J Code of Hygienic Practices and are correctly implemented and controlled. Establish Standard Operating Procedure (SOPs) to reduce microbiological risk within the test laboratory and production environment; provide review or approval of SOP’s as assigned. Conduct hygienic practice audits of the test laboratory and production environment. Troubleshoot equipment and methodologies; communicate microbiological risk to customers. Provide reports, trend analysis or feedback to inform management of quality trends and to establish corrective actions. Support Quality Management Review and provide the compliance of the site. Prepare and present numerous written and verbal reports indicating hygienic state of the facility including deviations, equipment design, corporate policy compliance and best practices. Support CAPA systems; lead investigation activities, provide effective corrective actions, provide review of reports associated with significant microbiological quality issues. Provide technical support to the new product introduction process, including review of raw material and finished product microbiological risk classifications, equipment train readiness, cleaning and sanitization practices, and remedial action plan development. Approve microbiological test method 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 policies 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, Contract Quality Assurance, travel to and consult with third party manufacturer’s to assess their hygienic readiness to produce product for J&J. Support off-shift operations and training opportunities. Perform other duties as assigned.
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A Bachelor of Science Degree is required. A degree in Microbiology, Biological or Science related with an emphasis in Microbiology is preferred. 10 years of related work experience including broad based experience or combination of experience in cosmetic/pharmaceutical manufacturing, facility/utility engineering, microbiology laboratory operations, quality operation and regulatory compliance is required. A significant knowledge of microbial quality assurance is required. A non-sterile OTC or pharmaceutical industry is preferred. Previous supervisory experience is preferred. A strong influencing skills in a cross-functional matrix environment is required.
This position could be located in either Fort Washington, PA or Lancaster, PA and will be required to travel 10% domestically.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement