Process Engineer II, Technical Compliance

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

• Work cross-functionally to implement changes within Operations.
• Ensure compliance of the manufacturing suites.
• Support audits, inspections, risk assessments, and CAL OOTs.
• Coordinate and perform compliance walkthroughs of the manufacturing areas.
• Support and own low risk change controls and participate in other change controls by performing impact assessments.
• Own multiple projects at a time and deliver milestones on time.
• Own activities such as CAPAs, change actions, and revising SOPs.
• Use operational and technical expertise to assist in implementing changes in manufacturing.
• Support urgent Planned Temporary Changes to ensure Operations is set up for Right First‑Time manufacturing.
• Ensure all production areas are in a state of compliance and audit ready at all times.
• Coordinate and perform monthly compliance walkthroughs and ensure follow‑up actions are completed.
• Serve as a functional area lead in the backroom during audits and inspections.
• Support audit response drafting and finalization.
• Initiate and close CAL OOTs.
• Participate in or perform risk assessments based on business need.
• Drive continuous improvement in the work processes associated with support of commercial manufacturing and change management.
• Support activities and projects that are in scope of the Technical Compliance Support team.

Minimum Requirements:

• BA/BS degree with any years of experience, or Associate’s degree with 4+ years of experience, or high school diploma (or equivalent) with 6+ years of relevant experience.
• Knowledge of process equipment and manufacturing operations.
• Ability to follow standard operating procedures and regulatory guidelines.
• Basic understanding of Current Good Manufacturing Practices.
• Strong organizational skills to manage project tasks and meet deadlines.
• Technical documentation skills for production and process approvals.

Preferred Requirements:

• Experience with in the pharmaceutical industry.
• Experience with writing Change Controls.
• Experience in deviations as responsible person.
• Familiarity with programs such as Veeva Vault, EAMS, PDOCs.
• Experience with Six Sigma or other operational excellence programs.

• Daily routine may require standing for long periods of time and/or walking throughout the suite, including up and down stairs.
• Must be able to don cleanroom gowns.
• Take necessary safety precautions when working within the manufacturing suites.
• Express ideas into SOPs, assessments, and use a multitude of programs including Excel, Word, Power Point, etc.

We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits 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.

This is a first shift, Monday to Friday role; however, this group supports the manufacturing suites which operate outside those hours. Occasionally support will be required outside of the normal first shift hours. This is an on‑site role with occasional work-from-home available. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the United States.

U.S. work visa sponsorship is not available for this role now or in the future.

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,…