Regulatory Compliance Officer

7 days ago


Rochester, New York, United States Unither Full time

About Unither

Unither is a leading pharmaceutical industrial group recognized for making affordable healthcare products that improve and simplify patients' lives.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

Our site in Rochester, NY, specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules, with over 280 employees.

Your Role

As a Validation Project Manager, you will report to the Senior Manager, Engineering, and be responsible for managing validation projects or multiple validation project activities under limited supervision.

Key Responsibilities

  • Execute protocols that ensure qualified systems and equipment (40%): Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities.
  • Develop and execute validation protocols for facilities, manufacturing equipment, manufacturing processes, cleaning, and critical utilities (40%): Write validation protocols for facilities, manufacturing equipment, manufacturing processes, cleaning, and critical utilities.
  • Process Improvements (20%): Keep abreast of industry current practices, and modify SOPs and validation practices to align with industry.

Requirements

  • Bachelor's Degree in Science or Engineering Discipline preferred.
  • Associates degree may be considered with relevant experience.
  • BS degree with 0-2 years. Co-op/internships preferred. 3+ years' relevant experience in validation, GMP or regulated environment and Associates degree will be considered.

Compensation

The compensation range for this position is $58,000 - $70,000 USD.



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