Manufacturing Technology Engineer I

Pfizer • Rocky Mount, NC

15h • Onsite

About The Position

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 I 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.

Requirements

• HS Diploma (or Equivalent) and 6 years of relevant experience OR an associate's degree with 4 years of experience OR a bachelor's degree with 0+ years of 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
• Must be able to lift and carry light loads as necessary in conducting testing.
• able to manage multiple tasks at once.
• Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.
• Permanent work authorization in the United States.

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 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.

Responsibilities

• 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 cGMP's.
• Create, review and approve deviations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.
• 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).

Benefits

• 401(k) plan with Pfizer Matching Contributions
• additional Pfizer Retirement Savings Contribution
• paid vacation
• holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED