Process Validation Manager

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. This senior level individual contributor position will provide process validation leadership for one or more vaccine or biologics drug substance manufacturing processes. The position leads and/or participates in the planning, preparation, execution, and summarization of process validation activities that comprise the Pfizer-Sanford process validation program. The role also provides input into validation assessments supporting investigations, change controls, and periodic reviews associated with the process validation lifecycle for a manufacturing process/product. The incumbent should be able to execute work independently, work with various groups across the organization, be a self-starter, and be able to oversee and lead project.

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

How You Will Achieve It

• Responsibilities include the following:
  

Leading process validation activities:

• Defining PV strategies in a process validation master plan
• Generating protocols, evaluating data, and writing final reports (PPQ, filter qualification, column or membrane cycling, uniformity/homogenaeity, hold time, etc)
• Process validation sampling oversight or coordination
• Generating of regulatory submission document subsections
• Project management of overall and individual PV projects and activities
• Authoring validation impact assessments for investigations.
• Authoring justifications for the assessment of change controls for process impact.
• Ability to manage multiple projects and activities of moderate complexity simultaneously.
• Liaise with site functions such as Manufacturing, Planning, QA, QC, Operations, and Regulatory Affairs as well as off-site functions such as PharmSci and Research and Development.
• Support regulatory inspections through the preparation, defense and interaction with auditors in areas related to process validation.
• The position requires execution and management of multiple projects at the same time and good communication skills to keep customers, peers, area management and site leadership up-to-date with progress of all projects in order to ensure validations are completed in a timely manner and on schedule.

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.
  
• Excellent written and verbal communication skill s (high level of English language proficiency).
  
• Previous process validation experience within pharmaceutical industry.
  
• High proficiency in Word, Excel and have demonstrated aptitude for computerized systems.
  
• High proficiency in validation technical writing.
• Ability to independently manage different projects, deadlines.

Nice-to-Have

• Previous tech transfer experience.
  
• Experience with defending validation packages to boards of health/regulators.
  
• B ackground in problem solving, negotiations, data integrity principles and project management/support in a matrixed reporting environment.
  
• Prior experience in other areas of validation (including equipment validation).
  
• Good understanding of risk management methodologies, with a proven ability to apply to Bio -p harmaceutical operations.
  
• Previous experience in bio-pharmaceutical industry.
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Schedule is primarily day shift but may require off-shift work on occasions. The position may require working on the floor in manufacturing at times which will require a heightened safety awareness and aseptic gowning will be required.

Relocation support available.

Work Location Assignment:On Premise

Last Date to Apply: February 19, 2024

The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% 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.

Quality Assurance and Control

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