Senior Validation Engineer

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.

ROLE SUMMARY

The Rochester Senior Validation Engineer is responsible for planning, scheduling, executing and leading various validation project assignments such as qualification, validation, and requalification activities related to manufacturing process, equipment, critical utility systems, product, cleaning, and/or sterilization processes. This role will also be responsible for the development/authoring of project plans, protocols, test scripts and reports throughout all life cycle of the process from initiation to continuous monitoring. The position will work closely with area owners and suppliers to finalize validation/qualification requirements for process, equipment and systems, ensuring that company policies, procedures, applicable regulations and guidelines are adhered to. This role will assist in troubleshooting, performing gap and risk assessments, provide support to regulatory and conduct training as required.

ROLE RESPONSIBILITIES

  • Support the validation/qualification of manufacturing equipment, facility and critical utility systems.
  • Support validation/qualification of product, cleaning, shipping, aseptic processing (media fill), and sterilization (steam) cycles
  • Support the validation/qualification of laboratory equipment
  • Develop/Author and execution of FRSs, URSs, FATs, SATs, DQ, IQ, OQ, PQ and other relevant validation life cycle documents
  • Develop/Author validation master plans, SOPs, programs and policies, system impact assessments, risk assessments and validation/qualification protocols (facility, equipment, process, product, change/modifications) and periodic requalification
  • Work cross functionally with multiple departments to schedule and complete all required activities
  • Support corrective actions including investigating and resolving deviations as relevant to validation
  • Support technical training on process and technology as required by the project
  • Support audit preparation and defend areas of Validation responsibility
  • Carryout process capability analysis on all commercial processes on a periodic basis. Identify areas for improvement where process capability is deemed to be unacceptable
  • Support for preparation and review of the relevant sections of the Annual Product Quality Reports (APQR)
  • Review site change controls to ensure the validated state of a process is not impacted by a proposed change
  • Lead the implementation of projects to reduce process risk, optimize plant and process productivity
  • Will required qualification in Aseptic Gowning and Techniques for cleanroom environments (Grade A through Grade D)
  • Role will require after hour and weekend support from time to time


QUALIFICATIONS

Basic Qualifications:
  • Must not have a Penicillin allergy.


Education:
  • BA/BS, or MS Degree in Bioprocess Science, Engineering, Biotechnology or equivalent with a preference for Biochemical, Chemical, Microbiology, or Biological disciplines, preferred.


Experience:
  • Minimum of 3 years related cGMP experience in Validation, Technical Services or Quality Operations preferred, for Pharmaceutical or Biotechnology industry
  • Strong working knowledge of a variety of quality systems and processes.
  • Prior experience in a GMP quality team environment strongly preferred.
  • The candidate must have demonstrated proficiency in organizational skills, balance multiple priorities, aptitude for technical learning, and problem solving.
  • The candidate must have experience in at least several of the following:

- Engineering design, facility/utilities and equipment qualification, process product validation, cleaning validation, sterilization validation, media fill, and Shipping validation

- Knowledgeable in both domestic and international GMP regulations and industry guidance documents (e.g. ICH, PDA, ISO, PIC/S, and ISPE), and incorporate continuous

improvements and best industry practice into validation activities and policies

- Strong understanding of risk-based validation approaches is desired

- Experience with system and process risk assessments

- Knowledge of drug/device combination products is highly desirable

Communication:
  • Excellent written and verbal 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 including senior leadership and regulatory agencies.
  • Ability to act decisively in real time and communicate/defend decisions with applicable areas of the organization.


Reasoning Ability:
  • Strong analytical, critical thinking and problem-solving abilities.


Technical:
  • Comprehensive understanding of cGMP guidelines outlined in CFR.
  • Knowledge and demonstrated ability to apply Pfizer Quality Standards to ensure local practices and procedures reflect these requirements.
  • Independently writes SOPs, technical reports, validation/qualification documents, project plans, etc.
  • Basic understanding of aseptic manufacturing highly desirable.


Preferred Qualifications:

Experience:
  • Minimum of 5 years related cGMP experience in Validation, Technical Services or Quality Operations working with Aseptic Drug Manufacturing Processes for Pharmaceutical or Biotechnology industry
  • Direct experience in developing and qualifying Clean In Place and Steam In Place Processes, compressed gas systems, Steam Sterilizer cycles, Temperature mapping of controlled temperature units/warehouse.
  • Conduct direct management of Aseptic Simulation (Media Fills) program.
  • Lead/Coordinator for the Change Control process involving qualified/validated systems.


PHYSICAL/MENTAL REQUIREMENTS

  • Must be able to lift a minimum of 30lbs
  • The position will require lifting, bending, and standing for periods of time, use of ladders and working within controlled environments.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Must not have a Penicillin allergy.
  • Minimal travel for training/seminars.


OTHER JOB DETAILS:

  • Last day to apply: 10/28/2021
  • Employee Referral Bonus eligible
  • Relocation support available


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 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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