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Sr Instrument Validation Specialist

2 months ago

Andover, Massachusetts, United States Pfizer Full time


Why Patients Need You

Pfizer is seeking a highly motivated and experienced candidate to support GMP activities for the validation group at the Andover site. This candidate is responsible for writing procedures, Requirement Specifications, investigations/deviations, commitments and change controls. This position requires working collaboratively with the QC raw materials, QC Analytical, QC Microbiology, Quality Assurance and Manufacturing groups.

In addition to validation, this candidate will manage change control action items and ensure on time closure of change controls. This candidate will actively participate in scheduling, visual management metrics, and continuous improvement activities. The successful candidate will be team oriented, have a passion for excellence, act with integrity, demonstrate equity and inclusivity, seek continuous improvement opportunities, actively participate in site recognition programs, and take pride in his or her contribution to the team.

What You Will Achieve

This position will provide support for the Instrument and associated software Validation Program at Pfizer Andover site.

The Senior Instrument Validation Specialist is expected to utilize their own subject matter expertise (SME), as well as collaborate with other site validation SMEs, to complete validation activities in compliance with corporate, regulatory, and industry standards and regulations.

The incumbent in this position will ensure Instrument validation activities are performed and maintained in a safe and cGMP compliant work environment and comply with company policies and regulatory/industry standards.

The incumbent will be expected to partner with the SME's of the site Quality Assurance Validation group to ensure all validation strategies and validation executions meet all applicable Pfizer quality and compliance standards, local SOP's, as well as applicable regulatory standards.

How You Will Achieve It

  • The Senior Instrument Validation Specialist is expected to utilize their own subject matter expertise (SME), as well as collaborate with other site validation SMEs, to define, standardize and support the instrument validation programs and procedures in compliance with corporate, regulatory, and industry standards and regulations.
  • This position will provide support for the validation program and validation projects at the Pfizer Andover site.
  • Authors, reviews and approves routine to highly complex instrument validation deliverables [Validation Plan, Validation Strategy, Requirements Specification, Qualification Protocols (IQ,OQ, PQ), Change Control Implementation Plans and Impact/Risk Assessment, deviations, investigations, corrective actions and/or preventive actions for adequacy, logic and quality/validation/regulatory impact], for appropriateness, completeness and alignment with quality, validation and regulatory expectation, providing sounds quality and compliance judgment to ensure meeting Pfizer Quality Standards, 21CFRpart11, ICH, MHRA, WHO guidance.
  • Provide technical support and fully implement change controls and commitments.
  • Execute test protocols associated with change controls and commitments.
  • Support internal and external audits.
  • Apply technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
  • Plan and prioritize projects and track completion rates for projects.
  • Demonstrated leadership skills in decision making, planning and prioritization. Focused on team success to meet defined metrics and timelines.
  • Proficiency with computer systems (Trackwise, Veeva Vault, PDOCS, LIMS, etc.).
  • Strong oral and written communication skills
  • Candidate must be self-motivated and be able to adapt to rapidly changing project priorities and prioritize projects appropriately.
  • Experience also required: background in problem solving, negotiations, and project management/support in a matrixed reporting environment. Candidate must be willing to work with vendors, QC, Manufacturing, Validation teams and have excellent customer service skills.
  • Knowledge and experience in cGMP USP/EP/JP, regulatory guidance and audits
  • Experience with DMAIC, lean, and continuous improvement tools desired
  • Exercises judgment in resolving moderate to high impact/complex instrument/equipment issues.
  • Incumbent knows and applies technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.

Qualifications

Must-Have

  • Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associate's degree with 6 years of experience OR a bachelor's with at least 3 years of experience OR Masters with more than 1 year of experience.
  • Strong understanding of instrument and software validation experience required.
  • Ample knowledge of GMP and regulatory requirements and data integrity principles.
  • Effective writing and oral communication skills.

PHYSICAL/MENTAL REQUIREMENTS

Normal sitting, standing and walking requirements to facilities and in a laboratory environment.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is first shift Monday through Friday. Some off hour support may be required to support staff and operations.

Work Location Assignment:On Premise

OTHER JOB DETAILS

  • Last Date to Apply for Job: October 30, 2023
  • Referral Bonus Eligibility: YES
  • Eligible for Relocation Package: NO

The annual base salary for this position ranges from $78,000.00 to $126, 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 ). 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.

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