Computer System Validation Supervisor

Computer System Validation Supervisor

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 Computer System Validation Supervisor to join our growing Validation team in Bloomington, Indiana.

Our Validation Supervisors are tasked with establishing validation policies/strategies to manage projects for biopharmaceutical manufacturing equipment, manufacturing process and laboratory documentation ensuring the deliverables meet the quality standards and requirements of Catalent’s policies and FDA regulations.

There is a significant opportunity to learn, develop, grow, trying new things and personally impact the business, our clients and ultimately the patients receiving the lifesaving products we manufacture. This role will help support the development and execution of validation project plans, user requirements, test strategies, electronic record and signature assessments, test protocols, and summary reports to address the Validation lifecycle (including developing GxP computer system validation and CFR 21 Part 11 related documentation).

This is a full-time salary position. The shift is Monday to Friday, days

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

• You will assist in the oversight of qualification activities for all capital expansion projects.
• You will assist with audits for validation/qualification documentation.
• You will provide coordination between all projects including QC analytical instruments.
• You will provide documentation and technical support to team members and clients in Quality Assurance, Quality Control, IT, Engineering, Manufacturing Operations, Investigations, and contractors supporting various site projects.
• You will support computer software assurance across the entire facility (including DeltaV, SCADA, and BMS automation systems).
• You will provide assistance with keeping finished products, equipment, processes, and facilities in compliance with contemporary industry standards and regulatory filings.
• You will support a computer system validation impact assessment for every new system purchased by the site for (Drug Substance, Drug Product Primary, Inspection, Packaging, and SSFFF).

The Candidate

• Bachelor’s degree in STEM discipline- REQUIRED
• Year of GMP experience, 3+ years preferred
• Years of leadership experience, 3+ years preferred
• Master’s degree or higher preferred

Why You Should Join Catalent

• 152 hours of PTO + 8 Paid Holidays
• Competitive medical benefits and 401K
• Opportunity to work on Continuous Improvement Processes
• Dynamic, fast-paced work environment

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

• Fosters Collaboration and Teamwork
• Engages and Inspires
• Delivers Results
• Leads with Integrity and Respect
• Champions Change
• Coaches and Develops
• Demonstrates Business Acumen

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

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