Process Facilitator

AstraZeneca•Philadelphia, PA

About The Position

The Process Facilitator provides direction to PET personnel to use equipment and materials efficiently and produce quality products in accordance with the PET plan. The role is responsible for PET activities, including coordinating support staff, scheduling, and process improvements. It promotes safe work practices and ensures external and AstraZeneca SHE standards are met, while ensuring cGMPs are followed to meet FDA and international regulations. The Process Facilitator trains PET personnel on equipment, processes, and standard operating procedures; maintains consistent documentation practices; and generates deviation reports, assists with investigations, and recommends or implements solutions. The role authors, reviews, and approves SOPs and other documents, collaborates with Engineering and Maintenance to optimize process performance, and participates in the design, selection, installation, and qualification of new equipment, facilities, and processes. It also reviews, approves, and implements change controls as appropriate. The role promotes a positive work environment through administration of AstraZeneca human resources policies and procedures, including performance management, communication, and response to employee concerns. It provides career development for direct reports, collaborates across PETs to ensure product flow and share best practices and lean behaviors, and acts as backup to the PET Lead when designated. The facilitator must be able to work any shift and collaborate with Process Facilitators across shifts. Duties may change at any time and this description is not an exhaustive list of responsibilities.

Requirements

Bachelor of Science in Engineering, Pharmacy, a related science, or business; alternatively, six years of experience in a people leadership role in lieu of a degree.
Minimum of five years’ experience in a GMP or regulated product environment.
Minimum of one to three years of previous supervisory experience.
Knowledge of FDA cGMPs.
Strong communication and leadership skills.
Strong troubleshooting and problem-solving skills.

Nice To Haves

Experience working in a Lean Manufacturing environment.
Ability to direct and participate in cross-functional teams.
Knowledge of or previous experience managing technical programs or projects.
Training or experience in formulation, filling, packaging, validation, technology transfer, or change control.
Project management skills.

Responsibilities

Direct PET personnel in the efficient use of equipment and materials to produce quality products in accordance with the PET plan.
Coordinate PET activities, support staff, scheduling, and improvements.
Promote safe work practices and ensure external and AstraZeneca SHE standards are met daily.
Train PET personnel on equipment, processes, and standard operating procedures.
Ensure cGMPs are followed during production to meet FDA and international regulations.
Administer AstraZeneca human resource policies and procedures, including performance management; communicate information to employees and respond to their concerns.
Maintain proper documentation practices in manufacturing documents, training documentation, production logs, and other records.
Generate deviation reports, assist with investigations, recommend and implement solutions, and approve deviation investigations as appropriate.
Author, review, and approve SOPs and other documents to integrate cGMPs and improve process efficiency.
Collaborate with Engineering and Maintenance to optimize process performance.
Participate in the design, selection, installation, and qualification of new equipment, facilities, and processes.
Review, approve, and implement change control as appropriate.
Provide career development for direct reports.
Collaborate within and across PETs to ensure product flow, share best practices, and promote lean behaviors.
Act as backup to the PET Lead when designated.
Work any shift and collaborate with other Process Facilitators across shifts.