As a Senior Tech Ops Engineer, you will play a crucial role in improving patients' lives while working at Pfizer. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives.
The Sr Tech Ops Engineer provides strategic direction and technical expertise for site Commissioning and Qualification (C&Q) activities for equipment, utilities and facilities. To include execution of C&Q work for utilities, facilities and global applications as well as maintenance and execution of periodic performance qualification schedule and reviews. This role serves as a Center of Excellence, driving alignment with global and industry engineering standards. The engineer supports site critical programs related to C&Q while also supporting capital project execution and site-wide technical initiatives. The position plays a key role in shaping the site’s technology roadmap, ensuring operational excellence, and fostering a self-sustaining technical work structure for the Focus Factory Manufacturing Technology teams.
In this role, you will:
S/he acts as the SME for C&Q work for Utilities, Facilities and Equipment across the site. Individual must have knowledge and application experience of technical design reviews, commissioning and qualification for pharmaceutical systems.
S/he 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, coordinates and supports testing associated with the development of new process technologies and the support of new systems introductions. S/he works closely with site Quality and Engineering resources to ensure appropriate C&Q of site systems is achieved and maintained against procedures and industry guidance. S/he plans, generates, 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 C&Q work. Provide ongoing training, guidance and templates to support the technical teams within the Focus Factories.
S/he will be expected to confirm C&Q 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. Support development and design of C&Q strategies, studies, draft and/or review project validation plans and documentation.
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. Review investigations, commitments, procedures, and batch records. 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 and existing systems.
Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
Solid knowledge/understanding of C&Q strategies
Understanding of various pharmaceutical equipment, utility and facility systems, preferably related to sterile injectable operations.
Solid 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 little direction
Good 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 multiple levels of the organization. Candidate must possess flexibility to respond to changing conditions and priorities.
Understanding of global regulations on GMP processes.
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.
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
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.
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