Media Validation Supervisor- Weekend AM (Thursday- Sunday 8am-6pm)

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.

Catalent is seeking a Media Fill Validation Supervisor to join our growing Validation team in Bloomington, Indiana.

Media Fill Validation Supervisors and their teams are responsible for the execution of the media fill program on automated filling lines, including preparing media fill batch records, technical support during media fills, supporting deviations closure on media fill batches, and writing and approving reports including media fill summaries, intervention trending, and operator training reports. Media fill supervisors and their team provide support to routine production for aseptic processing questions and escalations.

This is a full-time salary position. The shift for this position is Thursday- Sunday 8am-6pm. The position oversees both Weekend day-shift and Weekend night-shift team members.

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

• Lead a team providing 24-hour onsite coverage to all aseptic filling lines
• Direct activities to support media fills, including media batch record issuance and reporting
• Identify and implement system and documentation improvements, including improvements associated with CAPAs and audits.
• Serve as the first point of escalation for aseptic processing questions that occur on weekends
• Participate in client and regulatory audits
• Support media fill SME Engineers as needed
• Support any investigation of deviations encountered during the execution of validations and/or continuous monitoring/verification activities and provide documentation to support the findings of the investigation
• Knowledgeable of current FDA guidelines and industry standards pertaining to cleaning validation
• Manage the activities and mentor 5+ direct reports to accomplish the scope of work within the validation department including hold and release tags, protocols and report development, execution of cleaning validation activities, and reviewing of Change Controls and regulatory filings.
• Assign jobs and monitor progress to ensure that duties are adequately carried out

The Candidate

• Bachelor’s degree in STEM discipline preferred
• Technical and/or group leadership experience, 3+ years preferred
• Year of GMP experience, 3+ years preferred

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 152 hours 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.