Lead CSV Engineer - Technical Services

Use Your Power for Purpose

At Pfizer, everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety.

As part of this role, the lead Engineer is expected to serve as SME for site Computer System Validation for a dynamic, 24/7 manufacturing operation. Resource to provide guidance to site technical teams for managing computer system projects to ensure compliance, reliability and functionality.  Help in preparing forecasts for resources for assigned projects.  Support as an individual contributor and/or providing leadership of a team of junior team members/contractor resources through CSV activities.  You will contribute your comprehensive knowledge of principles, concepts/theories of the CSV discipline towards advancing new concepts/strategies and methodologies.  Individual to work as a technical SME/leader to facilitate agreement among cross functional team members.  

Ensures all project documentation is generated per the schedule, executed on time and that it is complete and accurate. Supports Data Integrity (DI)initiatives and maintenance of DI compliance associated with manufacturing processes and controls.

What You Will Achieve

In this role:

• S/he acts as the SME for CSV work for Utilities, Facilities, Equipment and infrastructure related computer systems across the site. Individual must have project management skills, knowledge and application experience of technical design reviews, commissioning and validation for pharmaceutical computer applications.  Individual will be expected to work routinely with cross functional groups throughout the site for process improvements and implementation. S/he must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to process improvements and changes. Person will be responsible for interfacing with auditors and presenting on site processes.
•  S/he organizes, oversees and analyzes testing associated with the development of new process technologies and the support of new systems introductions. S/he works closely with site and global DI, Quality and Engineering resources to ensure appropriate validation of site systems is achieved and maintained against procedures and industry guidance. S/he plans, reviews and approves site technical reports, to include validation plans/protocols, design specs, Risk Assessments.
• S/he will be expected to ensure site alignment to global procedures and work instructions related to CSV. Development and maintenance of site documents related to CSV. Provide ongoing training, guidance and templates to support the technical teams within the Focus Factories.
• S/he will be expected to confirm validation pre-requisites are met and supported by approved documentation in accordance with procedures and industry standards. Oversee and assist team members and contractor resources with their assigned projects. Develop and design validation strategies, studies, draft and/or review project validation plans and documentation. Participate, present and defend data including but not limited to regulatory agencies. customer. corporate or internal requests.
• S/he to provide input in technology transfer, risk assessments, validation deviations and/or quality deviation investigations to identify root causes and define correction and/or preventive actions (CAPA). Author and/or review risk assessment documents that support Computer Systems.  Review and approve investigations, commitments, procedures, batch records as they relate to CSV applications. Provide technical input and complete SME impact assessment to proposed change controls vetted for implementation.  Participate in teams assembled to complete change control implementation for new computer systems introduced to the facility.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of
  relevant experience. 
• Solid knowledge/understanding of CSV strategies.
• Understanding of various computer systems/applications related to pharmaceutical equipment, utility and facility systems.
• Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.
• Must be self-motivated and work with minimum direction.
• Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.
• An aptitude for understanding process technology and controls applications, decision making ability, and excellent oral and written communication skills are essential. Demonstrated ability to interact effectively with all levels of the organization. Candidate must possess flexibility to respond to changing conditions and priorities.
• Demonstrated understanding of global regulations on data integrity, GAMP guidelines, general GMP/GxP, and FDA 21 CFR Part 11 requirements.
• Must understand basic manufacturing processes and data recorded both electronically and on paper records.

Bonus Points If You Have (Preferred Requirements)

• Technical writing experience.
• Experience with pharmaceutical industry validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices.
• Working knowledge of Food and Drug Administration (FDA) Regulations/Guidance, and Good Manufacturing Practices (GMP).
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
• Strong background in problem-solving, negotiations, and data integrity principles.
• Experience in project management/support within a matrixed reporting environment.
• Good understanding of risk management methodologies and their application to Bio-pharmaceutical operations.

 
 

PHYSICAL/MENTAL REQUIREMENTS

• Remains organized & positive in ambiguous and fast-paced, rapidly changing environment.
• Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure.
• Ability to process complex information and make recommendations with incomplete data set.
• Ability to adjust work schedule to meet business needs – overtime, off shift, weekends.
• Ability to travel.
• Able to stand for extended hours for test runs and performance monitoring of processes – will include working within special gowning for cleanroom access.
• Able to climb ladders/steps.
• Able to lift items of 25lbs.
• Strategic thinker for issue resolution.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Pfizer operates 24/7 across most of the business units. Employee must have the ability to work extended hours, holidays and/or weekends as needed. Limited travel may be required to support OEM equipment design reviews and/or Factory Acceptance Testing of new equipment. Employee will be expected to periodically work within clean room areas requiring special gowning.

Work Location Assignment: On Premise

Last Date To Apply: November 28, 2025

The annual base salary for this position ranges from $96,300.00 to $160,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. 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.

Quality Assurance and Control