Sr Associate Technical Engineer
About The Position
The Sr Associate Technical Engineer is a key member of the Pfizer PGS Pearl River team, accountable for implementing, executing, and sustaining site Continuous Improvement projects and Validation Master Plan program elements for clean utilities and equipment cleaning. The role manages validation and equipment project deliverables and establishes project targets, milestones, and goals aligned with the site master validation plan and Continuous Improvement elements. The position supports pharmaceutical and biotechnology manufacturing, including associated clean utilities and CIP systems. It develops and executes validation deliverables, authors and reviews technical documentation and procedures, and coordinates project work with site functions and vendors. The role also supports operational huddles and regulatory and internal audits. The job is performed on premise and involves approximately 25% shop-floor presence. Work may require clean-room gowning while working around cytotoxic materials, pressurized systems, steam, and corrosive chemicals. Occasional off-hours work, including evenings and weekends, may be needed.
Requirements
- Associate degree with 5 or more years of experience; BA/BS with 2 or more years of experience; or MBA/MS with any years of relevant experience.
- Knowledge and experience with cGMP and FDA rules and regulations.
- Proficiency in data analysis and trend monitoring.
- Experience using common AI tools, including generative tools such as ChatGPT or Microsoft Copilot, to support problem solving and productivity, with curiosity about improving outcomes and understanding of responsible AI practices, risk management, and ethical use.
- Strong ownership and accountability, with the ability to lead change with agility, optimism, and innovation.
- Excellent organization and time-management skills.
- Ability to collaborate effectively within and across functions and communicate issues and solutions to the PCT and senior management.
- Ability to perform a full work shift under clean-room conditions with heavy gowning requirements, as necessary.
- Ability to move heavy equipment, stand for extended periods, walk throughout a suite including on stairs, and lift approximately 50 pounds.
- Ability to take necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals; heavy hands-on mechanical ability or capability.
- Permanent U.S. work authorization; candidates must be authorized to work in the U.S. by any employer. U.S. work visa sponsorship is not available.
Responsibilities
- Develop and execute cleaning validation and clean utility equipment qualification protocols and reports to support the site master plan.
- Author, review, and approve technical reports and development studies supporting clean utilities, equipment cleaning, and equipment projects.
- Author and review periodic reviews for utility equipment, filters, and cleaning validation.
- Author, review, and approve new and modified Standard Operating Procedures and Job Aids supporting manufacturing, clean utility equipment, and processes.
- Author, review, and approve Validation Plans, Risk Assessments, and Validation Strategies.
- Manage assigned project milestones supporting new processes, technology transfers, or equipment installations in collaboration with Operations, Opex, and Engineering.
- Manage vendor and contract resources to ensure their work aligns with Pfizer standards.
- Participate in PCT operational huddles (Tier 1/2) and shift huddles (Tier 0).
- Support regulatory and internal audits, including coordinating internal responses.
- Coordinate Validation Master Plan deliverables across Operations, Technical Services, Engineering, Supply Chain, QC, and QA, and work with project teams of up to 10–15 colleagues.
Benefits
- 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
- Medical, prescription drug, dental, and vision coverage
- Eligibility to participate in Pfizer’s Global Performance Plan with a bonus target of 10% of base salary
- Relocation assistance may be available based on business needs and/or eligibility
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
