Process Engineer II, Technical Compliance

Process Engineer II, Technical Compliance

Support Pfizer’s Technical Compliance team in ensuring that all manufacturing suites comply with regulatory and operational standards. Work cross‑functionally to drive project milestones, manage change controls, and maintain audit readiness within the manufacturing environment.

• Contribute to and complete project milestones, organizing work to meet deadlines.
• Drive own projects to completion, ensuring timely delivery of project objectives.
• Use operational and technical expertise to assist in implementing changes in manufacturing.
• Support urgent Planned Temporary Changes so that operations remain compliant.
• Maintain compliance of all production areas, ensuring audit readiness at all times.
• Coordinate and conduct monthly compliance walkthroughs and follow up on action items.
• Serve as the functional area lead for audits and inspections in the backroom.
• Draft and finalize audit responses.
• Initiate and close CAL OOTs.
• Participate in or perform risk assessments as needed.
• Drive continuous improvement of support processes related to commercial manufacturing and change management.
• Support additional activities and projects within the Technical Compliance Support scope.

• 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.

• 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 and/or walking throughout the suite, including up and down stairs.
• Must be able to don cleanroom gowns.
• Must take the necessary safety precautions when working within manufacturing suites.
• Must be able to express ideas into SOPs, assessments, and use a variety of software programs including Excel, Word, and PowerPoint.

First shift, Monday to Friday. Occasionally, support will be required outside of normal first‑shift hours. This is an on‑site role with occasional work‑from‑home available.

The annual base salary ranges from $68,600 to $114,300. Eligible for the Pfizer Global Performance Plan with a 7.5% bonus target. Pfizer offers comprehensive benefits, including 401(k) plan with matching contributions, paid vacation, holiday and personal days, caregiver/parental leave, medical, dental, vision, and wellness programs.

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 complies with all applicable laws governing nondiscrimination, work authorization verification, and E‑Verify. This position requires permanent work authorization in the United States.

Pfizer may report payments and other transfers of value to health care providers in accordance with federal and state transparency laws. If you are a licensed physician who incurs recruiting expenses reimbursed by Pfizer, those expenses may be reportable under the Sunshine Act.