Associate Engineer, Clinical Manufacturing

$54,700 - $91,100/Yr

Pfizer - Andover, MA

Full-time - Entry Level

Andover, MA

Chemical Manufacturing

About the position

As an Associate Engineer in Clinical Manufacturing at Pfizer, you will play a crucial role in the production of phase I/II clinical drug substances that support the Biotherapeutics portfolio. This position is integral to ensuring that our pharmaceutical manufacturing team can deliver breakthroughs to patients in need. You will be part of a multi-disciplinary team that adheres to current Good Manufacturing Practices (cGMP), contributing to the completion of complex projects and managing your own time to meet agreed targets. Your commitment and domain knowledge will foster a collaborative environment, essential for achieving project goals and milestones that ultimately benefit patients globally. In this role, you will support the completion of cGMP documentation and execute downstream mammalian and microbial purification processes within a cGMP environment. You will also be responsible for identifying and resolving quality concerns, contributing to investigational reports within the quality system. Your recommendations for continuous improvement will focus on enhancing safety, quality, and efficiency in our operations. Additionally, you will assist with tooling, change parts, and perform in-process operational checks associated with clinical manufacturing. You will work with various electronic systems, including Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), and Enterprise Resource Planning (ERP) systems like SAP. Understanding data integrity principles and their application within these systems will be essential. You will also support and troubleshoot process equipment, including Clean-in-Place (CIP) and Steam-in-Place (SIP) operations, ensuring that all processes meet the highest standards of quality and compliance.

Responsibilities

• Contribute to the completion of complex projects and manage own time to meet agreed targets.
• Support completion of Good Manufacturing Practices (cGMP) documentation.
• Execute and troubleshoot downstream mammalian and microbial purification processes in a cGMP environment.
• Identify and support the resolution of quality concerns and contribute to investigational reports within the quality system.
• Make recommendations for continuous improvement opportunities regarding safety, quality, and efficiency.
• Assist with associated tooling, change parts, and perform in-process operational checks associated with clinical manufacturing.
• Work in electronic systems including QMS, Documentation, Laboratory Information Management System, and ERP systems like SAP.
• Understand data integrity principles and their application within systems.
• Support and troubleshoot process equipment and Clean-in-place (CIP) and Steam-in-place (SIP) operations.

Requirements

• Bachelor's Degree in a relevant field.
• 0 to 2 years of relative experience in a biotechnology manufacturing or laboratory environment.
• Ability to execute against Standard Operating Procedures and document entries in a compliant manner.
• Demonstrated capability to work as a team member in a matrix development team.
• Maintains a safe work environment.
• Excellent oral and written communication skills.
• Strong analytical and computer skills.

Nice-to-haves

• Experience in a Biological Pilot Plant or Commercial Manufacturing setting.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation
• Paid holidays and personal days
• Paid caregiver/parental leave
• Paid medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage
• Eligible for Employee Referral Bonus
• Participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary.