Process Facilitator, Formulation - Mount Vernon, IN | Biospace
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Process Facilitator, Formulation

AstraZeneca Pharmaceuticals LP

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Location:
Mount Vernon, IN
Posted Date:
6/28/2017
Position Type:
Full time
Job Code:
R-009256
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location:Mount Vernon, Indiana, United States
Job reference: R-009256

Posted date: Jun. 13, 2017



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 the Process Facilitator, Formulation in Mount Vernon, IN you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
As the Process Execution Team (PET) Process Facilitator, Formulation, you are a leader for the Process Operation (ie. Manufacturing / Packaging). As the Process Facilitator, you will manage the Process / Formulation 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:

• 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, including coordination of support staff, scheduling and improvement
• 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
• Accountable for training of PET personnel on equipment, processes and Standard Operating Procedures. Partner with PET Coach to develop training plans and assist in providing resources for training
• 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
• 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.
• Generate reports for deviations, assists in the investigations, and recommends/implements 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
• Occasionally perform rolls for PET Lead when designated

Essential Requirements
• Bachelor of Science in Engineering, Pharmacy, related Science or business
• Minimum 5 years experience in a GMP or regulated production environment
• At least 1-3 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

Internal and External Contacts/Customers
• PET & other PETs (including other PET Process Facilitators)
• Maintenance Facilitators
• Technology and Engineering
• OEM suppliers
• Maintenance Planner
• Quality Assurance
• Regulators
• PET engineers
• Other Supply & Demand Sites

Direct/Indirect Reports
• Direct Reports – 15 – 20 guideline
• Indirect Reports - 0

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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Requirements

Please See Description