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)

• Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates 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 $96300.00 to $160500.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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 providers 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.

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Quality Assurance and Control