Manufacturing Senior Specialist

PCI Pharma Services•Bedford, NH

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 Senior 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. Incumbent collaborates with the manufacturing department in the execution of production across multiple shifts against department operational goals. This position will be the SME within the operations processes and is expected to be extremely versed in validation, regulatory and quality requirements as it pertains to cGMP. As the process operations subject matter expert, the incumbent is expected to take a lead role in process improvement initiatives.

Requirements

10+ years’ experience with GMP, ISO and/or an FDA regulated environment is required.
6+ years of experience in a cGMPs/ISO environment in an operations role.
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 within operations
Bachelor’s Degree in a Science or Engineering related field preferred
Intermediate/advanced PC skills, MS Office and Microsoft project applications is 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
Detail oriented with strong mechanical aptitude
Sets the example for fostering collaboration and teamwork
Assertive, self-directed, and results oriented
Honesty, integrity, respect and courtesy with leadership and peers
Strong commitment to conducting PCI PHARMA SERVICES business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI PHARMA SERVICES products and services
Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment

Responsibilities

Ensure efficient operation of process floor activities by developing/improving processes, materials, GMP and safety controls
Collaborate with the Quality, Operations, Material Management, Engineering, MTS, Validation, Facilities, Finance, and R&D teams to optimize processes, applying Lean principles
Drive efforts to address regulatory compliance issues related to production.
Work closely with Operations Management to provide guidance to staff in alignment with cGMP requirements, department goals and corporate quality standards
Proactively identify, assess, 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 are aligned to cGMPs/ISO and corporate standards
Author and perform investigations, deviations, CAPAs, and other GMP documentation and ensuring timely completion
Ensure work done by enabling/support groups is completed to standards.
Participates in inspections conducted by external regulators, as required
Identify continuous improvement opportunities to improve processes and practices and makes 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, you will train potential operations trainers and operators
Acts as Liaison and SME for new projects, creates processes and appropriate SOPs
Other duties as assigned