PET Senior Process Facilitator

Astra Usa   •  

Mount Vernon, IN

Industry: Biotech/Pharma


8 - 10 years

Posted 357 days ago

Major Responsibilities:

  • You will provide 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
  • You will be responsible for all PET activity to include coordination of support staff, scheduling and improvement.
  • You will promote the use of safe work practices during all aspects of production and ensure all external and AstraZeneca SHE standards are met on a daily basis.
  • You will be 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.
  • You will ensure that cGMP’s are used and followed during production of products so that all FDA and international regulations are met. Respond to monthly internal audit observations.
  • You will promote 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.
  • You will ensure proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.
  • You will generate reports for deviations, assists in the investigations, and recommend/implement solutions to resolve deviations. Approve deviation investigations as appropriate. Respond to product defect notifications.
  • You will author, review, and approve Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
  • You will promote and encourage 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.
  • You will collaborate with OE Engineers & PET Engineers to optimize process performance.
  • You will participate in the design, selection, installation and qualification of new equipment, facilities, and processes.
  • You will review, approve, and implement change controls.
  • You will provide career development and performance management for direct reports.
  • You will co-own life cycle management of PET/facility assets
  • You will work collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors.
  • You will maintain presence across multiple operating shifts.
  • You will occasionally performs rolls for PET Lead when designated.

Essential Requirements:

  • Bachelor of Science in Engineering, Pharmacy, related Science or business
  • Minimum 7  years’ experience in a GMP or regulated production environment
  • At least 4 year previous supervisory experience
  • Knowledge of FDA cGMP’s
  • Strong communication and leadership skills
  • Problem solving skills

Desired Background:

  • Experience working in a LEAN manufacturing environment
  • Working knowledge of 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

Job reference: R-016164