Manager, Equipment Validation

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

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. In your role, you will join a team which is responsible for the establishment and execution of the validation strategy for a given sector of validation (i.e. equipment, computer system validation, etc.) to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies. More broadly, you will be joining a department which aims to foster a culture of compliance and continuous improvement amongst all personnel who operate within the Validation team.

Working in a team-based environment, the Head of Equipment Validation or Manager, Equipment Validation (depending on experience level) will direct work of the equipment and facilities validation teams and provide them with leadership and mentoring. This individual will be responsible for implementing and sustaining the equipment and facilities validation program ensure high quality product is consistently manufactured using facilities, equipment & processes that have been appropriately designed and proven effective. He/ she will ensure validation activities are compliant, efficient and cost effective. The incumbents will lead a team to manage work for a single facility, or will co-manages the equipment and computer system validation program at Pfizer-Sanford appropriate regulatory agency requirements, internal Pfizer Quality Standards and industry best practices (depending on level of expertise and experience).

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

ROLE RESPONSIBILITIES

• Oversight for a group or groups managing equipment validation in one or more areas of bacterial vaccine manufacturing or mammalian cell culture unit operations, as well as support areas (cell banking and warehouse) at the Pfizer-Sanford site, from initial validation (small $$ capital projects only) through on-going requalification/re-evaluations, including validation contributions to product-based periodic reviews for licensed manufacturing processes.
• Oversight for contract workers supporting the technical operations equipment validation program.
• Contribute to or Co-lead EQV/CSV program strategies and procedure curation between TechOps and Engineering functions, including responsibilities for compliance with current cGMP regulations, Pfizer Quality Standards and industry guidance regarding relevant EQV/CSV program validation practices and procedures.
• Review and approve SOPs dealing with relevant validation processes.
• Leadership/managerial responsibilities for direct reports (EQV team leads): examples include, provide leadership to subordinates by managing, mentoring, coaching and developing them towards professional and personal growth, enhanced job performance and career satisfaction.
• Partner with DR to estimate, propose, and maintain team budget.
• Represent Pfizer-Sanford EQ/CSV program at above site/global equipment validation forums for reviewing trends across the PGS sites.
• Defend equipment validation packages during internal and external audits/inspections.
• Other related duties as assigned or required.

Qualifications

Must-Have

• Applicant must have a High School Diploma (or Equivalent) with 10 years of relevant experience; OR an Associate's degree with eight years of experience; OR a Bachelor's degree with at least five years of experience; OR a Master's degree with more than three years of experience; OR a Ph.D. with 0-2 years of experience.
• Previous supervisory/management experience and demonstrated ability to actively participate in the resolution of technical challenges and technical advances.
• Previous equipment validation experience.
• Demonstrated problem solving, decision making, negotiating and conflict resolution skills. Must have demonstrated skills in quantitative analysis, team facilitation and effective communications (both oral and written).
• Relevant experience in pharmaceutical or biopharma industry.

Nice-to-Have

• Experience /exposure to computerized system validation.
• In-depth understanding of GMP and regulatory standards.
• Experience with supporting regulartory inspections from various Boards of Health.
• Project management experience.
• Familiarity with budgeting, and capacity planning/resource allocation processes.
• Demonstrated ability to effectively lead and manage change.
• Proven history of effective performance management, coaching, mentoring and commitment to mutual accountability.
• Must demonstrate personal agility and innovation as well as cultivating similar behavior in team members.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Validation activities and troubleshooting can occasionally during non-routine business hours or on weekends due to alignment with manufacturing schedules. Flexible work schedule is required for possible remote support during these activities.

Relocation support available

Work Location Assignment:On Premise

Last Date to Apply: April 1, 2024

The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. 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.

Quality Assurance and Control