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 cGMP's. 

• 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 bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience

• Excellent attention to detail