Use Your Power for Purpose

At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world.

What You Will Achieve

• Provide direct production support during commercial operations via expertise of process equipment and systems, manufacturing operations, and automation control (Delta V, PLC, etc).

• Additional services include review of process requirements and evaluation of equipment and systems to ensure deliverables meet or exceed process specifications and manufacturing requirements.  Will provide technical guidance and systems and automation training to production colleagues. Provides controls/automation technical engineering support of cGMP clinical and / or commercial manufacturing processes and equipment working with the Manufacturing Area Leads.

• Analyzes equipment and process issues and supports related investigations. 

• Advise management of non-conformance issues and opportunities for continuous improvement via data trend analysis, interpretation of data, gap analysis and implementation of corrective activities. 

• Provides input on decisions for SOP’s, batch records, forms or other cGMP related documents developed or revised to support continuous improvement efforts, investigation corrective actions, process descriptions, manufacturing operations, automation control (DeltaV, etc.) and regulatory audit commitments.

• Evaluates new processes for commercial / clinical production in Train 5. This includes facility fit analysis and direct input into tech transfer documentation. This may also include new capital equipment purchases and implementation of new technologies.

• Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Pfizer Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc. 

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelor’s degree in Chemical Engineering, Electrical Engineering / Science (or related fields), Biomedical Engineering is required with at least 2 years of experience in an FDA regulated industry OR Master’s degree in Chemical Engineering, Electrical Engineering / Science (or related fields), Biomedical Engineering is required. with more than 0 years of experience in an FDA regulated industry OR an Associate’s degree with 6 years of experience in an FDA regulated industry, OR High School Diploma (or Equivalent) and 8 years of relevant experience in an FDA regulated industry.

• Prior experience with Distributed Control Systems is required.

• Knowledge of scientific principles, operational and design aspects of production equipment, automation control systems, and processing requirements. 

• Experience with writing software test plans, user requirements, computer systems validation, and system design documents.

• Demonstrated ability to interact effectively with colleagues at all levels of the organization to keep customers, peers, and area management up to date with progress of all projects to ensure automation activities are completed in a timely manner and on schedule.

Bonus Points If You Have (Preferred Requirements)

• Understanding of programming and proficiency in at least one language.

• Broad understanding of systems architecture and operations and related components (e.g. hardware, software, network, database, S88/S95 etc.).

• Experience in general GMP operations, single-use technology and tech transfer.

Physical / Mental requirements

• Ability to stand for extended periods of time on manufacturing floor. Ability to perform mathematical calculations and ability to perform complex data analysis.

Non-Standard work schedule, travel or environment requirements

• Adhere to safe work practices dependent on the manufacturing area (aseptic gowning).

• Ability to work off-hours shifts (2nd or 3rd shifts) on a rotating basis as applicable to support processing needs.

Other job details

• Last day to apply: Feb 18th, 2025

• Relocation Support available

• Employee Referral eligible

• Work