Manager/TL Environmental Compliance/Micro Services
The Environmental Compliance/Micro Services Manager / TL will be primarily based in Sterile Product Manufacturing building (SPM) and the Sterile Product Support (SPS) building and will provide general oversight to the Environmental Control personnel and provide Microbial Services support to the Sterile Product Manufacturing process. The ideal candidate will possess a working knowledge of aseptic processing requirements, good documentation practices (GDP), good manufacturing practices (GMP) and compliance/regulatory requirements relating to aseptic processing. Develops, directs and leads the Environmental Compliance Oversight of aseptic production activities at the Brentwood campus for St. Louis MMT Operations. In support of site wide objectives, coordinates the Environmental Compliance Technicians support activities, review and approval of area documents such as SOPs and validation protocols from a microbiological/environmental compliance standpoint. Provide Environmental compliance oversight to support aseptic production activities programs involving microbial and particulate control in production areas – cleaning and sanitation, disinfectants, training programs, etc. Coordinates micro support of validation related activity and production preparation, operation and environmental compliance overview. Engaged with cross functional teams as needed to support continuous improvement activities. Assure that Aseptic Manufacturing and Quality Assurance procedures and practices are aligned with Pfizer Quality Standards (PQS). Requires decision making ability related to Incident Investigation, Corrective and Preventive Actions with emphasis on aseptic quality, site priorities, results and achievements. Candidate will be responsible to provide leadership and participate in environmental data release, change control review and approval, manufacturing support, record approvals, investigation review, lab testing changes and project support within the quality organization.
- This position leads a team of Environmental Compliance supervisors supporting three shifts with a wide range of responsibilities. The incumbent is responsible for the development, mentoring, and performance management of a team of environmental compliance technicians and supervisors.
- Become the subject matter expert and main point of contact for microbial technical support for the aseptic manufacturing areas.
- Ensure documentation practices and systems are in place in compliance cGMPs and standard operating procedures.
- Work with management teams to ensure programs are in place to support and measure technical skill development.
- Partners with other Pfizer groups to support identified learning initiatives, as needed. Participates in network sterile injectables meetings (i.e. Aseptic Forum) to bring in Best Practices where required.
- Supports operational excellence and site transformational initiatives.
- Facilitates M1 investigations when required.
- Support process to hire, develop, coach, reward and monitor training and communication staff members.
- Set and implement objectives and development plans for direct staff as well as indirect departmental and on-the-job training.
- Support regulatory inspections
- Bachelor of Science degree required (preferred degree in Microbiology, Biology, Chemistry or related technical physical science). Master Degree in related discipline preferred.
- Minimum of 7 years of related experience. Previous experience as a manager of colleagues is required; two or more years of experience in GMP Aseptic or Sterile Manufacturing environment.
- Knowledgeable of current trends in Aseptic Manufacturing standards and regulatory compliance requirements for Pharmaceutical/Biological manufacturing (FDA, EU) preferred.
- Ability to read, analyze and interpret common scientific and technical journals, financial reports (as needed), and legal documents; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; respond to regulatory agencies; and respond to complaints from customers. Ability to gather and analyze information skillfully and present in many forms.
- The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities. The candidate should have experience in at least several of the following: GMP, Regulatory (worldwide), deviation investigation, drug product lot release, aseptic manufacturing processes, product and process validation, laboratory testing and investigations, and batch record review.
- Support communication process improvements throughout the site and enable replication of good practices between Pfizer sites.
- Support production of site-wide meetings and special events and visits.
While performing the duties of this job, the employee is occasionally exposed to general laboratory and/or manufacturing areas; work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate; required to stand; walk; sit; talk or hear; must occasionally lift and /or move up to 25 pounds; specific vision abilities require by this job include ability to adjust focus.
Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements. Must have the ability to work effectively under and manage to strict production, time and performance deadlines. Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays. If necessary travel to other locations.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (“green card holders”), Refugees and Asylees.
Last Date to Apply for Job: October 15, 2021
Eligible for Relocation Support
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Quality Assurance and Control