Validation Lead - West Chester, OH | Biospace
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Validation Lead

AstraZeneca Pharmaceuticals LP

West Chester, OH
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: West Chester,
United States
Job reference: R-008043

Posted date: May. 26, 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 Validation Lead in West Chester, OH, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

As the Validation Lead, you are responsible for the site Master Validation Plan and for ensuring qualification and validation systems are in compliance with regulatory guidelines and standards.

You will provide leadership to the Validation Department and manage the design, administration, coordination, documentation and performance of facility, utility, process, cleaning, automation
and computer system validation activities in a sterile manufacturing site.

Essential Job Functions:
Responsible for site Qualification and Validation Plans that include process validation, packaging validation, cleaning validation, equipment qualification, utilities and facilities qualification, and computer system validation.
• Develops, implements, integrates, and sustains validation systems to enhance compliance in accordance with ICH guidelines Q8, Q9, and Q10.
• Creates and implements changes in the Qualification programs to enhance compliance, reduce costs, improve customer service, and strengthen technical base.
• Collaborates with various engineering system owners such as process, packaging, and automation to reduce product cost and increase productivity while sustaining or improving the validated systems. Manages and controls validation documents for the Technical Services Department.
• Serves as a subject matter expert for process, sterile processing, packaging, and cleaning qualification and validation systems for site regulatory inspections.
• Collaborates with R&D during technical transfers to integrate Continued Process Verification (CPV) into on-going product trending. Monitor CQAs, CPPs, etc. for product/ process reliability.
• Develops and maintains effective relationships with internal and external customers, regulators, and other stakeholders.
• Updates, reviews, and approves area procedures to ensure compliance with Good Manufacturing Practices.
• Solves qualification issues using critical analyses skills; develops sound, reasoned solutions and recommendations.
• Evaluates new projects or existing equipment modifications, in terms of qualification and calibration needs, regarding the quality impact.
• Manages the qualification activities associated with all Quality Investigations.
• Participates as a member of the site Quality Council.
• Coordinates and participates in the investigation and resolution of product quality problems.
• Leads and participates in organizational teams to promote continuous quality improvement.
• Makes effective financial and operational decisions to positively impact both short and long-term objectives.
• Ensures that cost improvement projects are completed to meet the preset goal.
• Develops and maintains an effective organization through effective selection, training and development, and performance management.
• Prepares annual reviews and discusses job performance with area staff. Reviews and approves transfers, promotions, merit increases, and disciplinary actions.
• Works in partnership with site SHE to ensure validation systems comply with environmental and safety regulatory standards.
• Maintains a safe work environment by ensuring that Department personnel follow site SHE policies and procedures.

Essential Requirements:
• Bachelor's degree required, preferably in Engineering or Life Sciences.
• 10 Years of experience in Pharmaceutical
• Strong understanding of cGMPs, demonstrated leadership, management, and technical capabilities.
• Demonstrated applied knowledge of ICH guidelines Q8, Q9, and Q10, Computerized Systems, Data Integrity and CPV.
• Excellent verbal, written, and interpersonal communication skills are essential. Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and operations staff.
• Experience in conceptual development, project management (planning and scheduling projects), design, and implementation of major capital projects.
• Strong understanding of cGMPs, demonstrated leadership, management, and technical capabilities.
• Knowledge and understanding of validation and qualification principles, project management, and change control principles.
• Ability to understand and utilize financial analyses to make good decisions in a manufacturing environment.
• Demonstrated ability to manage a multi-disciplined technical staff.
Desired Requirements:
• Master's degree is highly desirable.
• Six Sigma green belt or equivalent experience is preferred.
• Experience with Lean Manufacturing is highly desirable.
• Experience in the Combination Product, or pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable.
• 5 years of experience in a sterile pharmaceutical environment.

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.


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