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Process Validation Specialist

2 months ago

Princeton, New Jersey, United States Dr Reddy's Laboratories Limited Full time
Job Overview

Company Overview
At Dr. Reddy's, we are committed to transforming healthcare by providing innovative solutions that improve the quality of life for patients. Our mission is to ensure that good health is accessible to all, and we are dedicated to fostering a diverse and inclusive workplace where every employee can thrive.

Position Summary
We are in search of a Technical Services Specialist to support New Product Launch initiatives. This role will report directly to the Head of Technical Services and will operate under a hybrid work model.

Key Responsibilities

  • Manage process validation efforts (PPQ) and offer life cycle management assistance for various products and technologies across internal and external manufacturing networks.
  • Design, plan, and implement process development and optimization studies, along with technology transfers for new business ventures within North America.
  • Provide expert guidance in addressing product and process technical challenges, including manufacturing investigations and corrective actions.
  • Draft, review, and execute cGMP documentation, which includes validation protocols, reports, standard operating procedures (SOPs), batch records, and change controls.
  • Conduct statistical evaluations for process validation and control.
  • Train staff and develop procedures for new equipment and processes.
  • Identify and explore opportunities for process enhancements.
  • Act as the technical authority for various processes and equipment.
  • Conduct technical due diligence of manufacturing facilities to support product outsourcing and the selection of contract manufacturing organizations (CMOs) for new product development and manufacturing.

Qualifications

  • Educational Background: Bachelor's or Master's degree in Pharmaceutical Sciences, Chemical Engineering, or a related technical field.

Experience Requirements:
A minimum of six to eight years of experience in the Pharmaceutical Industry, with a focus on sterile formulations preferred.

Skills and Attributes:

  • Experience in areas such as sterile formulations, solid dosage manufacturing, liquid and semi-solid manufacturing, and packaging.
  • Comprehensive understanding of cGMP regulations, pharmaceutical processing, process and equipment validation, cleaning validation, and documentation practices.
  • Familiarity with SUPAC guidelines in the pharmaceutical sector.
  • Strong interpersonal skills to effectively engage with personnel at all levels and with customers.
  • Exceptional technical communication skills, both written and verbal.
  • Proficient project management capabilities and strong computer skills.
  • Recognized as the go-to expert for resolving technical issues.

Additional Information
Dr. Reddy's is an Equal Opportunity Employer. We value diversity and encourage applications from all qualified individuals, regardless of race, color, religion, age, sex, sexual orientation, gender identity, national origin, or veteran status. We are committed to providing an inclusive environment for all employees.