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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 making essential medicines accessible and innovating treatment solutions to meet unmet medical needs. Our mission is to empower individuals to lead healthier lives, and we are looking for passionate and motivated professionals to help us achieve this goal.

Commitment to Diversity
We value diversity, equity, and inclusion in our workplace. At Dr. Reddy's, we strive to create an environment where every team member feels valued and included, and we welcome candidates from all backgrounds.

Position Summary

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

Key Responsibilities
  • Manage process validation activities (PPQ) and provide lifecycle management assistance for various products and technologies across both 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.
  • Offer expert guidance in addressing product and process technical challenges, including manufacturing investigations and corrective actions.
  • Draft, review, and execute cGMP documentation, such as 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:
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 communicate with all levels of personnel and clients.
  • Exceptional technical communication abilities, both written and verbal.
  • Proficient project management skills and computer literacy.
  • A reliable resource for resolving technical issues.

Additional Information
We foster a culture that values empathy and dynamism, believing that a diverse team united by a common purpose can achieve remarkable outcomes.

Equal Opportunity Statement
Dr. Reddy's is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against based on disability.