Senior Media Fill Validation Technician- Weekday PM

Position Summary:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 

A Sr Media Fill Validation Technician will participate in validation projects relating to Aseptic Process Simulations, Mixing and Hold Studies, and Process Performance Qualification (PPQs). This technician will help provide oversight to the media fill program including operator training and qualification, approach to coverage of all products in the media fill program and intervention strategies.

This is a full-time, hourly position. The shift is Monday - Wednesday 6:00pm - 6:30am, with rotating Thursdays.

Catalent Biologics in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.  

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role

• Coordinate Media Fill schedule, execution and movements with Manufacturing and Quality Control.
• Help support media fill execution, inspections, and growth promotion with a cross-functional team.
• Assist with writing media fill summary reports.
• Plans, reviews and approves Media Fill Batch Records
• Review process changes and provide input on media fill program
• Partner with validation teams to support mixing and hold studies for various clients
• Support media fill related investigations and implement corrective or preventative action and performance improvements
• Identify exceptions associated with validation protocol execution
• Review atypical interventions (Media Fill, only)
• Support resolution of production situations involving aseptic processing capabilities (Media Fill only)
• Observe Aseptic Process Simulation (APS) (media fill) executions to ensure compliance with the APS program policy and procedures
• Review atypical interventions and support resolution of production situations involving aseptic processing capabilities .
• Perform necessary assessments of aseptic operation and update necessary documents

The Candidate

• High School Diploma or GED- required
• 5-8 years of experience- required
• 1 year GMP or other regulated industry preferred
• Must be able to read and understand English-written job instructions and safety requirements

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• 19 days of PTO + 8 paid holidays
• Dynamic, fast-paced work environment
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• Competitive salary with quarterly bonus potential 
• Community engagement and green initiatives 
• Generous 401K match and Paid Time Off accrual 
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement 

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 is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.