Associate Manufacturing Engineer

Pfizer

73d • $66,500 - $110,900

About The Position

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

Requirements

• 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.
• Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding.
• Working knowledge of Food and Drug Administration Regulations and Good Manufacturing Practices.
• Proactive, with experience in high-performance teams, strong interpersonal and project management skills.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Applications.
• Ability to work effectively in a team environment and collaborate with cross-functional teams.

Nice To Haves

• Demonstrated experience in a relevant manufacturing environment.
• Knowledge and experience with Drug Substance processing and equipment.
• Experience with process validation and equipment qualification.
• Familiarity with Lean Manufacturing principles and Six Sigma methodologies.
• Excellent organizational skills and attention to detail.
• Strong leadership and mentoring abilities.
• Ability to adapt to changing priorities and work effectively under pressure.

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.

Benefits

• 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.
• Health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees