Sr Associate, HVAC and Facility Qualification
Job Description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
Pfizer Sanford provides Drug Substance and Drug products to facilities around the globe. This position is designed to support the HVAC Certification and Verification activities at the Pfizer Sanford facility that serve classified manufacturing areas for vaccines and gene therapy processes.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate explaining difficult issues and establishing consensus between teams.
The incumbent works as part of a cross-functional team to perform technical tasks as they relate to support for Facility Qualification activities, including HVAC certification/recertification, facility qualification activities, including Environmental Monitoring Performance Qualification (EMPQ), and periodic reevaluations for facility qualification packages to keep Pfizer-Sanford GMP facilities in a compliant state to produce vaccines and gene therapy products.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Support HVAC certification and facility qualification efforts by:
Troubleshooting and supporting decision-making efforts associated with manufacturing facility environments, including HVAC/AHU, Biosafety Cabinets (BSC), isolators, etc.
Author technical documents, including EMPQ protocols, qualification final reports, and occasional protocol non-conformance reports. Revise existing facility qualification procedures and guidance documents as needed.
Use project management and/or time management skills to organize and prioritize tasks as needed.
Create, edit and/or maintain SOPs detailing instructions for technical assessments. Follow procedural instructions relating to role and associated responsibilities, providing suggestions for continuous improvement to increase efficiency.
Qualifications
Must-Have
Applicant must have High School Diploma (or Equivalent) with ten years of relevant experience; OR an associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year of experience.
Previous experience working with HVAC trouble shooting, certification, or another element of facility qualification for cleanroom type environment.
Strong English language verbal and written communication skills.
Ability to work in ateam environment and manage projects independently.
Nice-to-Have
Technical writing and evaluation skills.
Experience with risk-based approaches (risk assessments).
Previous experience with Environmental Monitoring Performance Qualification.
Previous experience with smoke studies/Airflow Visualization Studies.
Previous project management/project lead experience, including oversight of contractors.
PHYSICAL/MENTAL REQUIREMENTS
Ability to enter and navigate cleanroom type environments in manufacturing facilities.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Schedule is primarily day shift, but at times it will be necessary to work additional times to support emergency manufacturing needs (either onsite or remote)
Work Location Assignment: On Premise
The annual base salary for this position ranges from $78000,00 to $130000,00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10,0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer 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 Eligibility
Pfizer 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. This position requires permanent work authorization in the United States.
Pfizer 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.