Sr. Associate Engineer, Drug Product Manufacturing

Responsible for providing engineering support and solutions that enable successful and innovative manufacturing of pharmaceutical drug products within Pfizer's state-of-the-art large molecule early stage clinical drug product manufacturing facility.

• This position's primary role is accountability for support of manufacturing by managing the lifecycle of all new and existing facility equipment and systems in a GMP compliant manner.
• Provide Engineering support to maintain equipment/systems in a GMP manner, including but not limited to:
  • Facilities/Utilities
  • Vial Washers
  • Depyrogenation Tunnels
  • Vial Filling Machines
  • Vial Labeling Equipment
  • Process Control System (SCADA)
  • Controlled Temperature Units (CTUs)
  • Lyophilizers
  • Autoclaves
  • Steam-in-Place/Clean-In/Out- of Place (SIP/CIP/COP)
  • Inspection Equipment
• Provide engineering solutions as both an individual contributor and/or as a member of a larger team.
• Engineering efforts will include support of all manufacturing operations required to produce drug product for clinical supply.
• This will include non-sterile, aseptic, and sterile processing steps.
• Interact directly with manufacturing operations, identifying opportunities to expand capability, increase efficiency and reduce manufacture downtime.
• Participate in on boarding new process equipment and systems as required. This includes User Requirement Specification development, Functional and Design Specification review, assistance to Validation group for commissioning and qualification execution.
• Assist with sustainable maintenance, decommissioning, and retirement of process equipment and systems.
• Create and maintain appropriate documentation to reflect as-built conditions for all relevant systems.
• Train in appropriate quality systems in support of Change Control management.
• Interact with Quality Group on as needed basis.

BASIC QUALIFICATIONS

• Bachelor's degree with 2-4 years of experience OR Master's degree with 0-2 years of experience in an Engineering discipline
• Aptitude in core engineering competencies
• Analytical and structured approach to problem solving.
• Scientific and mathematical analysis.
• Willingness to learn and apply basic team effectiveness skills (e.g., commitment, feedback, consensus management) within context of a Work Team environment.
• Ability to work in a matrix team environment interacting with Process Development, Manufacturing, Regulatory, Compliance, and Quality.
• Strong attention to detail, along with excellent communication and collaboration skills.
• Execute work in a structured environment under direct supervision using established procedures to perform assigned tasks.
• Responsible for team deliverables as required per project.

PREFERRED QUALIFICATIONS

• Chemical, Mechanical or Biomedical Engineering degree.
• Ability to work independently and complete deliverables with little guidance.
• Organizes own work to meet project task deadlines.

Other Job Details:

• Last Date to Apply for Job: March 9, 2021
• Eligible for Employee Referral Bonus: YES

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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