Principal Manufacturing Specialist

Catalent Biologics in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of manufacturing, and related pharmaceutical services. Manufacturing operations consist of Bulk Drug Substance manufacturing (Bioprocess), syringe filling (3 lines), vial filling (3 lines), cartridge filling (1 line), inspection and packaging. All open aseptic filling operations takes place inside Isolator systems. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.

This is a permanent, full-time on-site position. It is an hourly role. The shift is Monday – Friday, 3:00 am-11:00 am.

A Principal Manufacturing Specialist provides direct technical support to operations area as it relates to documentation, equipment procurement, testing, operational excellence, and training. This role works collaboratively with multiple company functions to ensure production systems operate in a safe, and quality-oriented manner. The Principal Manufacturing Specialist’s primary duty is to provide support for all Client and Regulatory Agency Audits and management of process and procedural improvements. The role will be “Process” related and the Specialist will act as the Subject Matter Expert. Responsibilities include: Ownership of Corrective Actions, Change Management, Audit Support as SME, GMP document revision, review and approval, lead and participate in continuous improvement opportunities.

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:

• Has advanced and specialized expertise in an analytical/scientific method or operational process, typically developed through a combination of job-related training and considerable on-the-job experience.
• Completes assignments and facilitates the work activities of others; may coordinate work beyond own area.
• Proposes improvements to processes and methods.
• Direct interaction with Client and Regulatory Auditors and leads and guides all tours related to client and regulatory audits.
• Competent at-risk mitigation for function.
• Write and revise SOP’s, WI’s, Batch Records, and Forms.
• Perform Investigations and Root Cause Analysis in Global Trackwise quality system utilizing technical writing skills.
• Other duties as assigned.

The Candidate:

• High School/GED with 8+ years’ pharmaceutical and/or manufacturing experience required; OR
• Associate degree with 5+ years’ pharmaceutical and/or manufacturing experience required; OR
• Bachelor’s degree in a manufacturing field of study with 3+ year pharmaceutical and/or manufacturing experience preferred.
• Audit and inspection experience required.
• 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
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly 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.