Specialist II - MTS/MSAT

About the role

The Manufacturing Technical Specialist provides technical (scientific/engineering) knowledge to enable GMP manufacturing, ensure regulatory compliance, and support direct client needs. This role supports PCI’s Aseptic and Non-Aseptic manufacturing processes, including Pharmaceutical Form/Fill/Finish and Medical Device manufacturing.

Responsibilities

• Provide technical support for the transfer of new processes with minimal supervision.
• Utilize manufacturing and GMP process knowledge to identify and resolve manufacturing issues, improve process operations, and drive positive change.
• Author Production Batch Record modules and SOPs for new processes; perform revisions/edits for existing records.
• Conduct complex investigations, document revisions, and manage documentation including batch production records and manufacturing procedures.
• Assist in specifying materials and components with cross-functional teams.
• Work with manufacturing Operations to develop and maintain production records compliance.
• Train manufacturing personnel to support Quality systems and batch documentation.
• Support technical studies for cGMP process/material implementation and quality system investigations/root cause analysis.
• Perform root cause analysis for investigations and risk assessments when required.
• Own and manage assigned manufacturing internal investigations, CAPAs, and supporting Quality documentation.
• Interact with clients to discuss and document decisions regarding manufacturing materials and processes related to Batch Records.
• Practice and promote safe work habits, adhering to PCI’s safety procedures and guidelines.
• Perform other duties as required to support PCI GMP Operations activities.
• Collaborate with aseptic, non-aseptic, and medical device Operations personnel, Project Management Leads, Quality Assurance, Validation, EHS, Engineering, Facilities, and clients.

Requirements

• Three or more years of experience in a technical or manufacturing role, or 3+ years of GMP experience in a regulated industry (pharmaceutical, biotech, or medical device).
• Knowledge of biopharmaceutical and/or medical product formulation, filtration, and filling operations.
• Preferred experience with operation of GMP scale manufacturing equipment.
• Familiarity with Quality Deviation Management Systems is a plus.
• Knowledge of Current Good Manufacturing Processes (cGMP), Regulatory Guidelines, Aseptic Manufacturing, bulk intermediate, and medical device manufacturing.
• Clean Room (Aseptic) experience is a plus.
• Experience in troubleshooting, investigation, and root cause analysis in a GXP environment.
• Bachelor’s or Associate degree in Life Science or a related field. Comparable blends of experience or education are acceptable.

Skills

• Excellent problem-solving and analytical skills.
• Proficiency in leading and performing Quality System Investigations.
• Proficiency with MS Office (Word, Excel, Access, PowerPoint, OneNote).
• Ability to work with aggressive deadlines while multitasking in a CMO environment, supporting multiple projects and activities.
• Excellent organizational and interpersonal skills; a team player.
• Excellent written and oral communication skills, with strong technical writing skills for composing GMP documentation, including master batch records and deviation/investigation management systems.
• Creative, adaptable, and able to work in a dynamic, fast-paced environment.
• Highly effective working with minimal supervision.
• Demonstrates flexibility, honesty, integrity, respect, and courtesy with all colleagues.