Validation Lead for Pharmaceutical Facilities

5 days ago


Troy, New York, United States BioSpace, Inc. Full time
About the Role
This position leads a team responsible for the qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in a Regeneron facility. The Validation Lead will participate and defend validation data in FDA and other regulatory inspections.

The day-to-day tasks of this role may include:
  1. Designing and developing policies related to validation and ensuring they are effectively administered and align with regulatory requirements.
  2. Being responsible for all aspects of QA Validation including review and approval of various types of documents such as failure investigations, change controls, SOPs, validation protocols, and validation master plans.
  3. Managing the Validation team by developing work plans, establishing objectives, and assigning tasks.
  4. Developing and managing validation budgets, contracts, and schedules.
  5. Presenting and defending validation data to FDA and other regulatory agencies.
  6. Maintaining validation document and software control systems while ensuring that validation status is maintained for equipment and software use in commercial and clinical manufacturing.

About You
To be successful in this role, you should have validation experience in a GMP environment, build and maintain strong working relationships across the business and with external partners, provide exceptional customer service, and have a continuous improvement mentality. Additionally, you should have supervisory/leadership experience and a Bachelors degree in Engineering, Chemistry, or Life Sciences with at least 7 years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes.

What We Offer
We offer an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. As an equal opportunity employer, we value diversity and inclusion and do not discriminate on any protected characteristic. The salary range for this position is $106,400.00 - $173,400.00 per year.

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