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.

What You Will Achieve

As a member of the Technical Compliance Support team, you will work cross-functionally to implement changes within Operations, ensure compliance of the manufacturing suites, support audits / inspections, support risk assessments, and CAL OOTs. You will coordinate and perform compliance walkthroughs of the manufacturing areas. You will support and own low risk change controls as well as participating in other change controls by performing impact assessments ensuring that the change will not negatively impact operations.

You will own multiple projects at a time and will be responsible for delivering to the milestones on time. You will also be responsible for owning activities such as CAPAs, change actions, revising SOPs. The Technical Compliance Support team supports all the manufacturing suites in Andover which will enable you to work with multiple teams within and outside Operations Support.

How You Will Achieve It

• Contribute to completion of project milestones and organize own work to meet project task deadlines.

• Drive own projects to completion.

• 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.

• Support audits and inspections by serving as a functional area lead in the backroom.

• 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.

Here Is What You Need (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.

Bonus Points If You Have (Preferred Requirements):

• Experience within 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

Physical/Mental Requirements

• 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.

• The incumbent needs to take the necessary safety precautions when working within the manufacturing suites.

• The incumbent must be able to express ideas into SOPs, assessments, and be able to use a multitude of programs including Excel, Word, Power Point, etc.

Non-Standard Work Schedule, Travel or Environment Requirements

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.

Other Job Details:

• Last day to apply: July 3rd, 2026.

The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% 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 | (uscandidates.mypfizerbenefits.com). 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.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Manufacturing