Technical Operations Engineer IV

Role Summary

Technical Operations Engineer IV at Pfizer. Lead Engineer and SME for site Computer System Validation (CSV) supporting a 24/7 manufacturing operation. Provides guidance to site technical teams on CSV projects to ensure compliance, reliability, and functionality; contributes to resource forecasting and may lead a team of junior members or contractors. Works as a technical SME to advance CSV concepts and facilitates cross-functional agreement. Supports data integrity initiatives and maintains DI compliance in manufacturing processes and controls.

Responsibilities

• Act as the CSV SME for Utilities, Facilities, Equipment and infrastructure related computer systems across the site; utilize project management skills and experience with design reviews, commissioning, and validation for pharmaceutical computer applications; collaborate with cross-functional groups for process improvements and implementation; interface with auditors on-site.
• Organize, oversee, and analyze testing for development of new process technologies and support of new system introductions; ensure validation is achieved and maintained per procedures and industry guidance; plan, review, and approve site technical reports including validation plans/protocols, design specs, and risk assessments.
• Ensure site alignment to global CSV procedures and work instructions; develop and maintain site CSV documents; provide ongoing training, guidance, and templates to support technical teams within Focus Factories.
• Confirm validation prerequisites are met and supported by approved documentation; oversee and assist team members and contractor resources; develop validation strategies, studies, and validation plans; participate in presentations to regulators, customers, corporate, or internal requests.
• Provide input on technology transfer, risk assessments, validation deviations, and quality deviation investigations to identify root causes and implement corrective/preventive actions (CAPA); author/review risk assessment documents; review investigations and batch records related to CSV; contribute SME input to proposed change controls; participate in change control teams for new systems.

Minimum Requirements

• Educational/Experience: Bachelor‚Äôs degree with at least 4 years of experience; OR Master‚Äôs with at least 2 years; OR PhD with 0+ years; OR Associate‚Äôs with 8 years; OR high school diploma and 10 years of relevant experience.
• Solid knowledge/understanding of CSV strategies.
• Understanding of computer systems/applications related to pharmaceutical equipment, utilities, and facilities.
• Strong leadership, organizational planning, and project management skills; ability to work with multi-disciplinary teams.
• Self-motivated with minimal direction; excellent interpersonal and communication skills (written and oral).
• Aptitude for understanding process technology and controls; ability to interact effectively at all levels; flexibility to respond to changing conditions and priorities.
• Understanding of global data integrity regulations, GAMP, GMP/GxP, and FDA 21 CFR Part 11; knowledge of basic manufacturing processes and electronic/paper data.

Preferred Qualifications

• Technical writing experience.
• Experience validating/qualifying pharmaceutical processes, equipment, utilities, facilities, and/or computer systems related to sterile products and medical devices.
• Working knowledge of FDA regulations/guidance and GMP.
• Ability to work independently and with others; proactive and results-driven.
• Strong problem-solving, negotiation, and data integrity skills.
• Experience in matrixed project management/support; knowledge of risk management methodologies in biopharmaceutical operations.

Physical/Mental Requirements

• Organized and positive in ambiguous, fast-paced environments; adaptable to changing priorities and able to meet deadlines under pressure.
• Ability to process complex information and make recommendations with incomplete data; flexible to work overtime, off-shifts, and weekends as needed.
• Ability to travel; ability to stand for extended periods for test runs; may require gowning for cleanroom access; ability to climb ladders; ability to lift up to 25 lbs.
• Strategic thinker for issue resolution.

Additional Requirements

• Pfizer operates 24/7; extended hours, holidays, and weekends may be required. Limited travel may be needed for OEM design reviews and Factory Acceptance Testing. Periodic work within clean rooms requiring special gowning.