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

You will lead North Creek’s Site Validation team and be responsible for all site validation activities in compliant and risk-based manner, and you will be responsible as the validation SME to represent site validation during health authority inspections. Your knowledge and skills will contribute towards the goals and objectives of the team and site, and your focus and ability to meet team targets will help in completing critical deliverables. You will also be responsible for the management and mentorship of your team to ensure they deliver on time, develop technically, and gain other skills to grow their careers.

It is your hard work, experience, and focus that will make the North Creek Manufacturing Facility validation program compliant, efficient, and ready to achieve heighten goals and help patients across the globe.

How You Will Achieve It
Provides technical oversight of validation systems, standards and documentation supporting new drug applications, product launches, technology transfers, facility and equipment modifications/upgrades, and modifications to existing formulations and processes

• Utilizes a risk-based approach to develop and maintain compliant, and cost-effective systems and procedures. Develops and supports procedures including Statistical Process Control and Continued Process Verification to enable robust and compliant manufacture
• Collaborates with IT and Quality to ensure the validation of computer systems used across GXP operations is conducted in compliance with applicable regulatory requirements and internal procedures
• Manages and leads a specialized team of validation engineers which supports the validation activities at the North Creek Manufacturing Facility
• Provides technical direction and guidance to all staff involved in validation activities (facility, equipment, process, CSV and cleaning)
• Interfaces with collaborates with Development/Process Sciences, MS&T SME’s, Manufacturing and QA teams to develop robust systems for identifying, challenging, qualifying, and trending Critical Process Parameters, Critical Quality Attributes, Control Strategies, and Sampling and Testing Plans
• Acts as an SME in inspections and communications with regulatory agencies
• Reviews and provides guidance on proposed changes to validated processes via CAPA and Change Controls to assess risk and identify requirements necessary to maintain a validated state

Qualifications
Must-Have

• Bachelor’s Degree in Biology, Chemistry, Engineering, or related Technical Physical Science required.
• 5 + years of experience in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required.
• Experience of facility, equipment, process, cleaning, shipping, computer systems validation
• Validation Leadership experience (team leadership, functional or discipline leadership)
• Extensive knowledge of pharmaceutical standards, regulations, current industry practices, and experience with interpretation and application of guidelines, regulations, and standards
• Experience in the management of Quality systems
• Proven track record with successfully managing validation programs in support of GxP Operations (Facility, Equipment and Process)
• Experience of fronting regulatory inspections on validation
• Fluency in spoken and written English is mandatory

Nice-to-Have

• A good understanding of statistical analysis and continuous process verification is desirable

 

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to gown for entering controlled areas.
• Must be able to wear specialized protective clothing, wear PPE (safety shoes/glasses/etc).

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• This role is primarily day shift, Monday – Friday, with 24/7 support of manufacturing as operational issues arise.
• Additional hours are worked as needed to keep up with deliverables.
• Some travel may be required but expected to be minimal (domestically and internationally to Pfizer sites and vendors).

Work Location Assignment: On Premise

The annual base salary for this position ranges from $131,200.00 to $218,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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.

Quality Assurance and Control