Process Facilitator - Packaging (Second Shift) - Newark, DE - Global Operations
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Process Facilitator in Newark, DE, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK
The Process Execution Team (PET) Process Facilitator is a leader for the Process Operation (ie. Manufacturing / Packaging).
As the Process Facilitator, you will manage 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, Safety, Health and Environment (SHE) obligations and AstraZeneca standards.
This position will be filled at either the Process Facilitator or Senior Process Facilitator level depending on the successful candidate's qualifications.
Responsibilities include but are not limited to:
- 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.
- Responsible for all PET activity to include coordination of support staff, scheduling and improvement initiatives.
- Promote and demonstrate 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 the training of PET personnel on equipment, processes and Standard Operating Procedures.
- Ensure that cGMPs are used and followed during the production of products so that all FDA and international regulations are met. Respond to monthly internal audit observations. Promote a QUALITY FIRST environment
- 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.
- Ensure proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.
- Lead deviation investigation efforts including generation of reports and recommendations/implementation of solutions to resolve deviations. Approve deviation investigations as appropriate. Respond to product defect notifications
- Author, review, and approve Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies
- 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
- Collaborate with OE Engineers & PET Engineers to optimize process performance
- Participate in the design, selection, installation and qualification of new equipment, facilities, and processes
- Review, approve and implement change controls
- Provide career development and performance management for direct reports
- Co-own life cycle management of PET/facility assets
- Work collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors
- Maintain presence across multiple operating shifts
- Act as delegate for PET Lead when designated
- Provide direction to PET personnel responsible for the disposal of hazardous waste materials
- Bachelor of Science in Engineering, Pharmacy, related Science or business.
- Minimum five (5) years' experience in GMP or regulated production environment
- Previous supervisory experience.
- Knowledge of FDA cGMP’s..
- Strong communication and leadership skills.
- Problem-solving skills.
- 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
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.