Principal Manufacturing Process Engineer

Pfizer • Sanford, NC

15d • Onsite

About The Position

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.

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

Nice To Haves

• Proven ability to work collaboratively in a cross-functional team environment
• Strategic planning and forecasting skills
• Ability to facilitate agreements between various teams
• Ability to work on own initiative.
• Strong technical management and organizational skills
• Good leadership and communication abilities
• Strong problem-solving skills

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.

Benefits

• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
• Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees