PET Process Facilitator
Apply NowCompany: AstraZeneca
Location: Philadelphia, PA 19120
Description:
NOTICE: This position will start as a 2nd shift (3:45pm - 2:15am M-Th - 10hrs) position until new unit is trained and then team will be moved (1Q2026) to 3rd shift (11pm - 7:30am M-F 8 hr day).
Accountabilities:
- Provide direction to PET personnel for efficient use of equipment and materials to produce quality products.
- Coordinate support staff, scheduling, and improvement activities within PET.
- Promote safe work practices and ensure compliance with external and AstraZeneca SHE standards.
- Train PET personnel on equipment, processes, and standard operating procedures (SOPs).
- Ensure adherence to cGMPs during production to meet FDA and international regulations.
- Foster a positive work environment by guiding HR policies and procedures, including Performance Management.
- Maintain accurate documentation practices in manufacturing documents, training records, and production logs.
- Generate reports for deviations, assist in investigations, and implement solutions. Approve deviation investigations as appropriate.
- Author, review, and approve SOPs and other documents to integrate cGMPs and improve process efficiencies.
- 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.
- Work collaboratively within and across PETs to ensure product flow, share best methods, and promote lean behaviors.
- Act as backup to PET Lead when designated.
- Ability to work any shift and collaborate with other Process Facilitators across shifts.
Essential Skills/Experience:
- Bachelor of Science in Engineering, Pharmacy, related Science or business, or High School Grad/GED with 6 years' experience in a people leadership role in lieu of degree
- Minimum of 5 years' experience in GMP or regulated product environment
- Minimum of 1-3 years previous supervisory experience
- Knowledge of FDA cGMP's
- Strong communication and leadership skills
- Strong troubleshooting and problem-solving skills
Desirable Skills/Experience:
- Experience working in a Lean Manufacturing environment
- Ability to guide and participate in cross-functional teams
- Knowledge or previous experience in managing technical programs/projects
- Training or experience in formulation, filling, packaging, validation, technology transfer, change control
- Project management skills
At AstraZeneca, we embrace constant challenges as intellectually stimulating opportunities to learn more. We grow with pushing boundaries while implementing the best systems with cutting-edge science and manufacturing. Our resilience helps us innovate and evolve as we deliver life-changing medicines to patients. We foster a safe and positive environment where ideas are encouraged and rewarded. Join us to make a significant impact on our future.
Ready to take the next step in your career? Apply now!
Date Posted
14-Apr-2025
Closing Date
29-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
Accountabilities:
- Provide direction to PET personnel for efficient use of equipment and materials to produce quality products.
- Coordinate support staff, scheduling, and improvement activities within PET.
- Promote safe work practices and ensure compliance with external and AstraZeneca SHE standards.
- Train PET personnel on equipment, processes, and standard operating procedures (SOPs).
- Ensure adherence to cGMPs during production to meet FDA and international regulations.
- Foster a positive work environment by guiding HR policies and procedures, including Performance Management.
- Maintain accurate documentation practices in manufacturing documents, training records, and production logs.
- Generate reports for deviations, assist in investigations, and implement solutions. Approve deviation investigations as appropriate.
- Author, review, and approve SOPs and other documents to integrate cGMPs and improve process efficiencies.
- 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.
- Work collaboratively within and across PETs to ensure product flow, share best methods, and promote lean behaviors.
- Act as backup to PET Lead when designated.
- Ability to work any shift and collaborate with other Process Facilitators across shifts.
Essential Skills/Experience:
- Bachelor of Science in Engineering, Pharmacy, related Science or business, or High School Grad/GED with 6 years' experience in a people leadership role in lieu of degree
- Minimum of 5 years' experience in GMP or regulated product environment
- Minimum of 1-3 years previous supervisory experience
- Knowledge of FDA cGMP's
- Strong communication and leadership skills
- Strong troubleshooting and problem-solving skills
Desirable Skills/Experience:
- Experience working in a Lean Manufacturing environment
- Ability to guide and participate in cross-functional teams
- Knowledge or previous experience in managing technical programs/projects
- Training or experience in formulation, filling, packaging, validation, technology transfer, change control
- Project management skills
At AstraZeneca, we embrace constant challenges as intellectually stimulating opportunities to learn more. We grow with pushing boundaries while implementing the best systems with cutting-edge science and manufacturing. Our resilience helps us innovate and evolve as we deliver life-changing medicines to patients. We foster a safe and positive environment where ideas are encouraged and rewarded. Join us to make a significant impact on our future.
Ready to take the next step in your career? Apply now!
Date Posted
14-Apr-2025
Closing Date
29-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.