Manufacturing 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 Manufacturing Specialist is Responsible for ensuring the manufacturing department (ex. equipment preparation, formulation, filtration, aseptic, non-aseptic compounding, preparation, packaging and filling activities) executes the production plan across multiple shifts against department’s operational goals. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.

Requirements

A Bachelor’s Degree in a Science related field
7-10 years of experience in a cGMPs/ISO environment.
Strong understanding of cGMPs/ISO
Experience with GMP, ISO and/or an FDA regulated environment is required
Experienced in making tactical decisions on safety, process, and scheduling issues
Experience working with cross-functional teams, including Quality, Manufacturing Technical Support
Experienced in troubleshooting, investigation, root cause and risk analysis in a CGMP environment
Ability to lift 25 pounds
Ability to stand, sit or remain in the same position for long periods of time
May be required to travel between sites

Responsibilities

Ensure safety of manufacturing area and work practices in accordance with all PCI Health, Safety and Environmental program.
Assists in coordinating of manufacturing personnel in the cGMP operations to meet all scheduled manufacturing work
Ensure efficient operation of process floor activities by developing processes, materials, GMP and safety controls
Guide and train employees to ensure QSR and ISO requirements have been properly implemented and are continually met.
Partner with Quality to ensure a cGMP operation
Assist team in planning and execution of manufacturing instructions in order to perform equipment preparation, compounding, filtration, formulation and fill activities for aseptic and terminally non-aseptic products in accordance with Good Manufacturing Practices (GMP) standard operating procedure, applicable Quality System and Regulatory requirements
Become a highly visible, hands-on team builder to motivate, coach, support, inspire and retain highly effective teams
Collaborate with the Operations, Material Management, Engineering, MTS, finance, and R&D teams to optimize processes, specifically applying Lean principles if applicable
Drive efforts to address regulatory compliance issues related to production.
Responsible for maintaining the highest level of regulatory compliance
Work with Manufacturing Supervisors to provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards
Partner with the Manufacturing Scheduler to ensure accuracy of and adherence to production schedules
Ensure that appropriate levels of trained resources are available to meet production schedules
Proactively identifies, assesses, and mitigates operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams
Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics
Ensure staff has appropriate knowledge of processes and procedures to perform responsibilities
Ensure manufacturing instruction set and production records reflect practice, are aligned to cGMPs/ISO and corporate standards
Collaborate with training to design department training plan and training plan execution.
Ensure Training materials are accurate and sufficiently detailed
Ensure timely completion of investigations and deviations and CAPAs.
Utilize quality metrics to measure, analyze, and improve team performance.
Ensure Real time batch review and "Right First Time"
Ensure Inspection readiness of assigned manufacturing areas.
Participates in inspections conducted by external regulators, as required
Identifies continuous improvement opportunities to improve processes and practices
Partner with cross-functional groups to evaluate and drive resolution of operational issues and proactively drive continuous improvement projects to completion
Act as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs
Assist in operations to provide training and guidance as necessary
Act as SME and primary trainer to potential operations trainers
Other duties as assigned