Tech Services - Senior Associate Engineer

Pfizer•Rocky Mount, NC

20d•Onsite

About The Position

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. What You Will Achieve 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

Acts as the SME for C&Q work for Utilities, Facilities and Equipment across the site.
Work routinely with cross functional groups throughout the site for process improvements and implementation.
Interface with auditors and presenting on site processes.
Organizes, coordinates and supports testing associated with the development of new process technologies and the support of new systems introductions.
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.
Plans, generates, reviews and approves site technical reports, to include validation plans/protocols, design specs, Risk Assessments.
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.
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.
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.

Benefits

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.

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