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 be a member of Pfizer’s dedicated and highly effective Computer System Assurance Team. In this role, You will be responsible for evaluation, review and approval of validation standard operating procedures, protocols and reports. Your methodological approach will help us ensure compliance of our computerized, automated, and laboratory systems with company standards and government regulatory requirements. Your problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to equipment, products and processes.

As a Sr. CSA Engineer, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

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

How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Comprehensive understanding of {Current} Good Manufacturing Practices {part of GxP} guidelines outlined in Code of Federal Regulations.
• Ensure compliance with latest Pfizer Quality Standards for validation and qualification activities.
• Engage in routine Quality systems, such as Change Control, Quality Agreement, Documentation and Investigations.
• Coordinate and communicate all testing with affected functional groups and evaluate test results.
• Provide expertise for trouble-shooting and resolution of issues related to equipment, instrumentation, facilities and utilities as it pertains to validation/qualification
• Assess potential impact of changes to qualified systems Identify and implement validation best practices to continuously improve the site validation program Represent engineering validation on site or network teams as necessary.
• Support validation as a Subject Matter Expert during customer and regulatory audits for all areas of responsibility.
• Ensure integration of validation schedule in production schedule for implementation of validation activities and conduct validation deviations, participate in deviation investigations to identify root causes and define corrective and/or preventative actions.
• Assist with and provide internal support to contract resources and other internal CSA & Validation team members
• Provide guidance, mentorship, and on occasion be required to guide less experienced engineers, technicians, or specialists.
• Author, execute, review, and approve validation lifecycle documentation.
• Work independently with minimal guidance
• Support the unit where needed to assure due dates and customer needs are met.

Qualifications

Must-Have

• Applicant must have a High School Diploma (or Equivalent) and eight years of relevant experience;
• OR an Associate's degree with six years of experience;
• OR a Bachelor’s degree with at least three years of experience;
• OR a Master’s degree with more than one year of experience
• Experience in {Current} Good Manufacturing Practices {part of GxP}
• Strong working knowledge of a variety of quality systems and processes
• Familiarity with information systems, such as Global Document Management System, (PDOCS)
• Strong verbal and written communication skills
• Ability to work in a team environment and manage projects independently
• Training in 21 CFR Part 11, GAMP, ISPE, and Annex 11
• Kneat experience
• Automation or programming knowledge
• Relevant pharmaceutical experience.
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to sterile products and medical devices
• Proven experience as a Program Manager
• Experience in {Current} Good Manufacturing Practices {part of GxP}
• Strong working knowledge of a variety of quality systems and processes
• Familiarity with information systems, such as Global Document Management System, System Application & Products and Quality Tracking System
• Strong verbal and written communication skills
• Ability to work in a team environment and manage projects independently

Nice-to-Have

• Relevant pharmaceutical experience.
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to sterile products and medical devices

 PHYSICAL/MENTAL REQUIREMENTS

• Requires routine sitting, standing, walking, listening and talking
• Acute mental and visual attention at all times
• Handle multiple projects while managing frequent interruptions
• Requires moderate lifting or moving up to 25 pounds (lbs)

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Work Location Assignment: On Premise
• Requires regular onsite attendance 
• Must have the ability to work effectively under strict deadlines
• Must be able and willing to work beyond office hours which may include weekends and holidays
• Must be capable of supporting up to 10% travel (domestic and international)

Other Job Details

• Eligible for Relocation Assistance
• Last Day to Apply: February 8, 2023

Relocation assistance may be available based on business needs and/or eligibility.

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.

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