Manufacturing Specialist Aseptic Training I

PCI Pharma Services•Madison, WI

28d

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. Summary of Objective: As part of the manufacturing team at the PCI-Madison Site, the Aseptic Manufacturing Trainer is identified as a subject matter expert with focused knowledge and skills in procedures, techniques, tools, materials, and equipment. They provide direct support to manufacturing personnel to ensure Good Manufacturing Practices (GMP) and core competencies are met. As an aseptic manufacturing trainer, you will be responsible for training manufacturing personnel and reinforcing proper cGMP behaviors in accordance with our SOP and manufacturing procedures and by applying your aseptic knowledge and prior professional work experience. The individual serving in this role will be required to maintain their own manufacturing and aseptic qualifications allowing them to be staffed to the production line based on business needs. This individual will be responsible for the daily training of new/tenured personnel. The incumbent will need to maintain and monitor all aspects of the trainee’s progression to ensure proper technique and knowledge are being demonstrated to the trainee throughout the entire training process. This role is a full-time position within manufacturing operations; the incumbent is responsible for training future trainers in the department as well, this will ensure sustainability of the training program. The individual serving in this role will also provide support on batch record review, deviation investigations, CAPAs, and other manufacturing documentation needs as required.

Requirements

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
Excellent communication skills both verbal and written
Assertive, self-directed, and a good team player with previous operations and experience in Six Sigma is a plus
Results driven: Collaboratively set realistic, challenging, measurable goals and timetable
Keep self and others focused on key performance indicators
Adaptability: Maintain effectiveness in continually changing work environment
Proven leadership, persuasiveness, initiative, project management, lean knowledge and problem-solving skills are necessary for success in this position
Adjust quickly to work within new work structures, processes, requirements or cultures
Safety oriented mindset
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
Ability to gown and gain entry to general controlled manufacturing areas.
Ability to gown and maintain entry into the ISO-05 Cleanroom area
Ability to wear personal protective equipment required for the area of work.
Bachelor’s Degree in a Science related field, preferred
At least 3 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
Experience working with cross-functional teams, including Quality, Manufacturing Technical Support, Engineering, R&D, Validation, etc.
Experienced in troubleshooting, investigation, root cause and risk analysis in a CGMP environment
Excellent planning and organizational skills and the ability to multi-task and meet deadlines in a fast-paced team environment is required
Strong internal customer service/people skills are required.
Excellent professional verbal, written and interpersonal skills are required.
Is flexible and adaptable to changing work demands.

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
Act as SME and primary trainer to potential operations trainers
Ability to effectively train manufacturing associates on the proper manufacturing curriculum, focused on OJT (on-the-job training) and related Standard Operating Procedures (SOP)
Develops, maintains, and organizes current and accurate manufacturing training material, learning activities, handouts, worksheets, job aids, and class evaluations
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, and MTS teams to optimize processes, specifically applying Lean principles if applicable
Drive efforts to address regulatory compliance issues related to production.
Work with Manufacturing Supervisors to provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards
Proactively identifies, assesses, and mitigates operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams
Ensure manufacturing instruction set and production records reflect practice, are aligned to cGMPs/ISO and corporate standards
Provide support of batch record review, deviations, and CAPAs to ensure timely completion.
Assist in the maintenance of department quality metrics to measure, analyze, and improve team performance.
Assist in 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
Other duties as assigned