Process Facilitator; 2nd Shift
AstraZeneca (Framingham/Worcester, Massachusetts)

This job posting has expired.

You may wish to try a search for Process Facilitator; 2nd Shift

Or visit the FlipDog home page
 

Description:
The PET Process Facilitator is a leader for the Process Operation (ie. Manufacturing/Packaging). In this capacity, the Process Facilitator manages the Process / Package Operation to produce high quality product in accordance with the PET operating strategy. As a responsible leader for the operation (potentially with other Process Facilitators), this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as SHE obligations and AstraZeneca standards.

Major Responsibilities:
· Provides direction to PET personnel in the efficient use of equipment and materials to produce quality products in accordance with the PET Plan or Rhythm Wheel
· Responsible for all PET activity to include coordination of support staff, scheduling and improvement.
· Promotes the use of safe work practices during all aspects of production and ensures all external and AstraZeneca SHE standards are met on a daily basis.
· Accountable for training of PET personnel on equipment, processes and Standard Operating Procedures. Partners with PET Coach to develop training plans and assist in providing resources for training.
· Ensures that cGMP’s are used and followed during production of products so that all FDA and international regulations are met. Responds to monthly internal audit observations.
· Promotes a positive work environment by effectively administering AstraZeneca Human Resources policies and procedures including Performance Management and by communicating information to employees and responding to their concerns.
· Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.
· Generates reports for deviations, assists in the investigations, and recommends/implements solutions to resolve deviations. Approves deviation investigations as appropriate. Respond to product defect notifications.
· Authors, reviews, and approves Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
· Promotes and encourages continuous improvement in efficiency, quality, production, and safety through the use of team driven processes and key performance indicators and recognition and rewarding high performance.
· Collaborates with OE Engineers & PET Engineers to optimize process performance.
· Participates in the design, selection, installation and qualification of new equipment, facilities, and processes.
· Reviews, approves, and implements change control.
· Provides career development and performance management for direct reports.
· Co-owns life cycle management of PET/facility assets
· Works collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors.
· Maintains presence across multiple operating shifts.
· Occasionally performs rolls for PET Lead when designated.

Responsibilities

Minimum Requirements (Education, skills and abilities)
· Bachelor of Science in Engineering, Pharmacy, related Science or business.
· Minimum 5 years experience in GMP or regulated production environment
· Minimum of 1-3 years previous supervisory experience.
· Knowledge of FDA cGMP’s..
· Strong communication and leadership skills.
· Problem solving skills.

Preferred Background
· Experience working in a LEAN manufacturing environment
· Working knowledge of TDMS, Microsoft applications, SAP, Trackwise
· Training or experience in formulation, filling, packaging, validation, technology transfer, change control.
· Knowledge or previous experience in managing technical programs/projects
· Strong mechanical, electrical, troubleshooting and problem solving abilities.
· Ability to direct and participate in cross-functional teams.
· Project management skills