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Pfizer · 1 month ago

Principal Manufacturing Process Engineer

United States - North Carolina - Sanford

Full-time

Onsite

Senior Level, Lead/Staff

$96K/yr - $160K/yr

4+ years exp

Pfizer is a global leader in the pharmaceutical industry, committed to delivering medicines to patients worldwide. The Principal Manufacturing Process Engineer will lead interdisciplinary teams to improve manufacturing processes and support production operations, ensuring compliance and efficiency in the manufacturing of mAb products.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

Responsibilities

Supports manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, drug product filling, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF 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

Qualification

MAb productsCGMPProcess EngineeringLean ManufacturingTechnical auditsProject managementProblem-solvingCommunication skillsTeam collaborationLeadership

Required

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