Validation Specialist
Validation Specialist
Position Summary
The Validation Specialist would be responsible for ensuring that processes and systems such as those associated with equipment, facility, utility, and computerized systems are installed, operate, and perform as specified; all commercial manufacturing processes are capable of reliably and repeatedly producing a product of the required quality; and all cleaning procedures will remove residues of any added cleaning or sanitizing agents and product to predetermined levels of acceptability.
Requirements:
The Role
This individual is responsible for writing, executing, and summarizing validation protocols, leading the development and maintenance specification documents (URS/FRS/DS/SDS), traceability matrices, and assisting in the development of validation plans. This role will also be required to analyze and summarize periodic reviews of previously validated systems and to develop and implement protocols/changes based on the outcomes of those reviews. Additionally, they will assist user groups in troubleshooting and analyzing of systems and lead the resolution of deviations noted during a systems lifecycle.
The Candidate
•BS in Engineering, or other scientific/technical related discipline.
•2 to 5 years experience in pharmaceutical/biotech environment.
•Strong experiences in at least one of the following areas: equipment (including laboratory equipment), facility, utility qualification, cleaning validation, process validation, or computer validation.
•Strong written and oral communication skills with ability to interact with various individuals and roles throughout the organization and with external consultants and contractors
•Results oriented, self-motivated, self-starter with flexibility to adapt to changing priorities, ability to manage multiple projects/activities simultaneously, and to deliver on aggressive project timelines.
•Working knowledge of good documentation practices and FDA/GMP regulatory requirements and guidance documents
We will identify candidates based on the following:
•Leads with Integrity and Respect
•Delivers Results
•Demonstrates Business Acumen
•Fosters Collaboration and Teamwork
•Champions Change
•Engages and Inspires
•Coaches and Develops
Position Benefits:
•Join a high growth and fast paced organization with a people focused culture
•Global exposure, defined career path and annual performance review and feedback process
•Competitive Medical, Dental, Vision and 401K
•19 days of paid time off annually + 7 paid holidays
About Catalent
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent. More products. Better treatments. Reliably supplied.
