Job Title: Shift Lead (Day) - Aseptic Isolator Manufacturing
We're committed to developing breakthroughs that change patients' lives. To achieve this, we've established clear expectations for what we need to accomplish and how we'll do it.
Pfizer Global Supply is responsible for manufacturing and distributing our pharmaceutical products worldwide.
The Shift Lead will support the qualification, validation, and commercial operation of a new isolator filling line for freeze-dried drug products in a new aseptic manufacturing facility.
You'll begin in the project phase as an integral member of the Operational Readiness team, supporting the development and implementation of aseptic processes and procedures.
Later, you'll transition to a Shift Lead role for daily operation supervision in a controlled manufacturing environment.
Key Responsibilities:
* Phase One: Operational Readiness Team
o Act as operations representative and Subject Matter Expert (SME) on specific equipment or processes.
o Support engineering team for qualification protocols based on pre-defined User Requirement Specifications (URS).
o Develop and implement Standard Operating Procedures (SOP) for manufacturing processes and operations.
o Evaluate process and procedure compliance with regulatory expectations.
o Ensure safety protocols are followed and conduct regular safety audits.
* Phase Two: Shift Lead (Mid 2025 to Early 2026)
o Oversight of machinability trials, Performance Qualification (PQ), and Aseptic Process Simulations.
o Maintenance of quality standards and regulatory compliance.
o Leadership of shift teams during commercial operations.
o Preparation of batch records and accurate production activity records.
o Identification and implementation of process improvements.
Requirements:
* Bachelor of Science, Engineering, or related field.
* In-depth understanding of manufacturing processes, quality standards, and regulatory requirements.
* Familiarity with sterilization methods and component/container/equipment preparation processes.
* Strong leadership, communication, and team management skills.
* Problem-solving abilities and proficiency in production management software and tools.
* Lean six sigma skills and experience in Upstream/Downstream Current Good Manufacturing Practices (cGMP) manufacturing operations.