Principal Process Engineer

This job is with Pfizer, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Use Your Power for Purpose   Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring that customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you will contribute to delivering medicines to the world at an accelerated pace by envisioning new possibilities and taking decisive action.

Your role in the design and development of manufacturing processes, as well as in maintenance and reliability support, is essential for providing timely access to necessary medications. Working alongside our innovative team, you will help expedite the delivery of medicines globally by imagining what can be achieved and making it happen.
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve      The  Principal Process Engineer  supports the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule for  mAb products .  The  Principal   Process Engineer  will lead interdisciplinary and cross functional teams, to own and implement process improvements, and lead/participate in process troubleshooting.

How You Will Achieve It
Supports  upstream   manufacturing operations on the production floor for buffer/media make-up tanks, parts washers, autoclaves, bioreactors, inoculum preparation, and/or harvest skids with varying levels of automation.

Point of Contact   for  the execution and issue resolution associated with process equipment commissioning, qualification and validation.

Owns  troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.

Delivers  Right first-time execution and continuous improvement;
Monitor, Identify and/or Communicate process and compliance trends in real time.

Participate in the authoring role  for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.

Collaborates with  the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.

Responsible for remaining current on assigned training.

Leads  Lean Manufacturing, Sustainability and Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.

Leads  in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.

Generates   work requests  when issues arise with facility / manufacturing equipment. Provides support to maintenance to facilitate resolution, when needed. Point of contact for emergency work orders.

Skilled  in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.

Identifies  the need for escalation through various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.

Lead  cross-functional project teams through high-risk technical assessments and develop complex engineering solutions.

Leads and coaches  beginner and intermediate Process Engineers through complex troubleshooting, investigations, and projects

Oversee and conduct  supplier technical audits and corporate audits.

Actively share  knowledge within the team through established systems.

Here Is What You Need (Minimum Requirements)       BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or Associate's degree with at least 8 years of experience or High School Diploma (or Equivalent) with at least 10 years of relevant experience

Demonstrated experience in product development, manufacturing science and technology, sterilization or process validation, or Process Engineering within the pharmaceutical industry

Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, and design control

Strong history of problem-solving skills, project and task management skills

Ability to manage priorities and lead others under pressure

Strong verbal and written presentation communication skills

Bonus Points If You Have (Preferred Requirements)       Proven ability to work collaboratively in a…