Manufacturing Specialist

PCI Pharma Services•Bedford, NH

1d•Onsite

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Manufacturing Specialist is responsible for assisting the manufacturing team in a variety of complex tasks in accordance with the FDA and other regulatory agencies’ expectations while following all safety and quality guidelines of PCI. The Manufacturing Specialist collaborates with the operations department in the execution of production across multiple shifts against department operational goals. This position will be the Subject Matter Expert (SME) within the operations processes and is expected to be highly versed in validation, regulatory, and quality requirements as it pertains to cGMP. As the process operations subject matter expert, the incumbent is expected to lead process improvement initiatives.

Requirements

5+ years’ experience with GMP, ISO, and/or an FDA-regulated environment is required.
3+ years of experience in an operations role in a cGMPs/ISO environment.
Strong understanding of cGMPs
Strong technical writer and SME in writing all Quality system documents (CAPAs, Deviations, Change Controls, etc.)
SME in troubleshooting, investigation, root cause, and risk analysis in a cGMP environment for complex issues within the production environment
Strong understanding of validation principles and practices to ensure compliance with operations.
Intermediate/advanced PC skills, MS Office, and Microsoft project applications are required
Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs
Proven leadership, initiative, project management, and problem-solving skills
Skilled in a range of manufacturing processes and procedures through on-the-job training and significant on-the-job experience
College Level Mathematical Skills

Nice To Haves

Bachelor’s Degree in a Science or Engineering related field preferred

Responsibilities

Ensure efficient operation of process floor activities by developing/improving processes, materials, GMP, and safety controls.
Collaborate/Assist with the Quality, Operations, Material Management, Engineering, MTS, Validation, Facilities, Finance, and R&D teams to optimize processes, applying Lean principles where applicable.
Organize and analyze large amounts of continuous manufacturing process data for process investigations, troubleshooting, and continuous process improvements requiring advanced data collection and analysis skills
Drive efforts to address regulatory compliance issues related to production.
Work closely with Operations Management to guide staff in alignment with cGMP requirements, department goals, and corporate quality standards.
Proactively identify, evaluates, and mitigate operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams
Ensure manufacturing SOPs and batch records reflect practice and align with cGMPs/ISO and corporate standards.
Author and perform investigations, deviations, CAPAs, CCR, and other GMP documentation and ensure timely completion.
Performing technical review of batch records and supporting data in collaboration with QA and QC for batch release
Ensure work done by enabling/support groups is completed to standards.
Participates in/supports regulatory inspections conducted by external auditors, as required.
Identify continuous improvement opportunities to improve processes and practices and make changes in conjunction with supervisors and operators.
Partner with cross-functional groups to evaluate and drive resolution of operational issues and proactively drive continuous improvement projects to completion
Successfully participate in media fill / aseptic proficiency test and maintains qualification if applicable.
Works within defined processes, steps, and methods and will assist in developing procedures for new assignments or tasks.
As the SME, assist in manufacturing operations to provide training and guidance as necessary
As the SME, the Manufacturing Specialist will train potential operations trainers and operators.
Acts as Liaison and SME for new projects, creates processes and appropriate SOPs
Other duties as assigned