Manufacturing Technical Specialist II (MTS)

PCI Pharma Services • Bedford, NH

1d

About The Position

The Manufacturing Technical Specialist II (MTS) provides essential technical (scientific/engineering) knowledge to support Good Manufacturing Practices (GMP) manufacturing and ensure regulatory compliance, including direct client support. This role is crucial for the company’s Aseptic and Non-Aseptic manufacturing processes, encompassing Pharmaceutical Form/Fill/Finish and Medical Device manufacturing. The MTS II assists with technical transfers by implementing client processes, developing and writing Batch Records, and preparing reports for technical studies. Additionally, the incumbent is responsible for Quality System support, including managing deviations, investigations, excursions, and CAPA execution. The role also involves developing, editing, and completing other cGMP documentation such as SOPs, material specifications, and training materials related to manufacturing operations and client specifications. The MTS Specialist II actively participates in and provides feedback for the PCI EHS Program to ensure adherence to Health and Safety regulations and OSHA requirements in all tasks.

Requirements

• Three 3+ years of experience in either 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.
• Knowledge of Current Good Manufacturing Processes (cGMP), Regulatory Guidelines, Aseptic Manufacturing, as well as bulk intermediate and medical device manufacturing.
• Experience in troubleshooting, investigation, and root cause analysis in a GXP environment.
• Bachelor’s Degree/Associate degree in life Science or a related field.
• Excellent problem solving and analytical skills required.
• Possess skills and techniques for leading and performing Quality System Investigations
• Proficiency with MS Office (Word/Excel/Access/ PowerPoint/One Note).
• Skilled at working with aggressive deadlines while multi-tasking.
• Requires excellent organizational and interpersonal skills, team-player.
• Excellent written and oral communication skills are required.
• Possess strong technical writing skills necessary for composing GMP documentation including master batch records and deviation/investigation management systems or a similar technical writing system
• Creative with the ability to work in a dynamic, fast paced work environment
• Honesty, integrity, respect and courtesy with all colleagues.
• A team player and contributing collaborator.
• Highly effective working with minimal supervision
• Demonstrates flexibility and adaptability in the work environment

Nice To Haves

• Preferred experience with operation of GMP scale manufacturing equipment
• Familiarity with Quality Deviation Management Systems is a plus.
• Clean Room (Aseptic) experience a plus.

Responsibilities

• Provide technical support for the technical transfer of new processes with minimal supervision.
• Utilize manufacturing and GMP process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations, and effect positive change.
• Author Production Batch Record modules and SOPs for new processes, and perform revisions/edits for existing records.
• Conduct complex investigations, document revisions, and/or document management, including batch production records, manufacturing procedures, and cross-functional 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 as needed to support Quality systems and batch documentation.
• Support technical studies for cGMP process/material implementation and for quality system investigations/root cause analysis.
• Perform root cause analysis for investigations and conduct risk assessments when required.
• Own and manage assigned manufacturing internal investigations, CAPAs, and supporting Quality documentation.
• Meet and interact with clients, as needed, to complete, discuss, and document client decisions regarding manufacturing materials and processes related to Batch Records.
• Practice and promote safe work habits and adhere to PCI's safety procedures and guidelines.
• Perform other duties as required to support PCI GMP Operations activities.

Benefits

• Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies.
• We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level.
• We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree