Technical Operations Engineer IV

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)

relevant experience.

Bonus Points If You Have (Preferred Requirements)

validation / qualification

of pharmaceutical processes, equipment, utilities, facilities and / or computer systems as related to sterile products and medical devices.

Regulations / Guidance,

and Good Manufacturing Practices (GMP).

PHYSICAL / MENTAL REQUIREMENTS

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

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 also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Pfizer endeavors to make

www.pfizer.com / careers

accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and / or interviewing, please email

disabilityrecruitment@pfizer.com

Quality Assurance and Control