Director, Process Validation - Technical Operations
Aldevron

Job Info

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In this role, you will have the opportunity to:

• Set direction and provide leadership of Process Validation programs employing a risk-based approach and enabling client projects to move from clinical to commercial production
• Develop and implement process validation policies and related procedures based on current regulations and industry standards to support the company's growth and regulatory requirements.
• Collaborate with cross-functional teams, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Manufacturing, to facilitate and drive process validation for clinical and commercial programs.
• Support additional areas of Validation focus, including Cleaning Validation), Water System Performance Qualifications, and Environmental Monitoring Performance Qualification (EMPQ).

The essential requirements of the job include:

• 7+ years of pharmaceutical industry with 5+ years of cGMP experience; Biologics CDMO experience preferred
• Bachelor's degree in chemistry, statistics, or science-based discipline with 7+ years of experience in the pharmaceutical or life sciences industry

It would be a plus if you also possess previous experience in:

• Knowledge of full validation life cycle and cGMP compliance
• Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality driven processes and end products

The salary range OR the hourly range for this role is . This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

This job has expired.