Manufacturing Technology Engineer II (Secondment 10 12 Months)

WHY PATIENTS NEED YOU

As a Manufacturing Technology Engineer you will be responsible for developing/validating/qualifying/Re-qualifying the processes systems equipment facilities used to manufacture and/or clean drug products within a large manufacturing facility located in Rocky Mount North Carolina USA. You will help to demonstrate that the processes and/or systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.

This individual ensures all Engineering documentation deliverables are generated and may be asked to develop new processes or optimize existing ones. This individual will support large scale projects; as well as coordinate all work including but not limited to coordination of personnel activities documentation and outside resources. The Manufacturing Technology Engineer will develop and manage project scopes for contractors and consultants in the support of project and process implementation. This role supports daily manufacturing processes by troubleshooting equipment or process issues investigational analysis and/or continuous improvement/corrective action initiatives. Supports Data Integrity (DI) initiatives and maintenance of DI compliance associated with manufacturing processes and controls.

As an engineer your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment you will create a collaborative teaming environment for your colleagues. It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

WHAT YOU WILL ACHIEVE

• Draft schedule and execute engineering studies/validations/qualifications per Standard Operating Procedures (SOPs) protocols and regulatory guidelines.

• Coordinates and communicates all testing with affected functional groups and evaluates test results.

• Execute engineering activities to include but not limited to: Change Control initiation protocol preparation periodic reviews routine requalification scheduling protocol execution data review and final report generation.

• Participate and/or present data in Regulatory Agency Customer Corporate and Internal audits when necessary.

• Participates on teams assembled to specify install validate troubleshoot and maintain processes systems and equipment.

• Develop and qualify production recipes for manufacturing processes.

• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conform to Pfizer policy and cGMPs.

• Create review and approve deviations.

• Help to define appropriate action plans for improvement and follow-up and communicate action closures.

HOW YOU WILL ACHIEVE IT

• Coordinates all work on scheduled projects needed to meet the deadlines developed by Plant Capital Plan New Product Introductions and New Process Technology Developments.

• Responsible for manufacturing engineering support the development of new process technologies and the support of new product introductions/tech transfers.

• Organizes testing associated with the development of new process technologies and the support of new product introductions/tech transfers.

• Works closely with site tech. services to develop and confirm Critical Process Parameters needed for Equipment and processes. Develops and delivers presentations to communicate project timelines and milestone completions.

• Design technical/engineering studies writes technical reports summarizing study results and generates necessary data to support process development for new equipment process changes commodity changes and/or investigation/CAPA support.

• Generate/Support site technical assessments (i.e. alarm risk engineering).

• Support execution of smoke studies and media fills for the aseptic filling areas.

QUALIFICATIONS

Must-Have

• Applicant must have a bachelors degree with 0 years of experience; OR an associates degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience

• Excellent attention to detail

• Excellent organizational skills and ability to handle changing deadlines

• Strong communication with written and verbal skills

• Working knowledge of Microsoft Office especially Excel for evaluation of data

Nice-to-Have

• 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 Regulations/Guidance and Good Manufacturing Practices

• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results

• Experience working with periodic performance qualifications (PPQ) Kaye Validator Filling Equipment (Fillers Cappers Tunnels etc) SIP Systems Isolator Systems is preferred.

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to lift and carry light loads as necessary in conducting testing. Weekend or long hours based on testing schedule.

• able to manage multiple tasks at once.

• May involve standing for long periods of time.

• Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

OTHER JOB DETAILS

• Last Date to Apply for Job:March 19 2026.

• Additional Location Information:N/A

• Eligible for Relocation Package NO

• Secondment 10-12 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for12 months or longer you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.

• There will be no change to your current work location.

• Position is considered Flexible and colleagues are expected to comply with Log In For Your Day(LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

Relocation assistance may be available based on business needs and/or eligibility.