Associate Manufacturing Specialist

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 Manufacturing Specialist's primary duty is to provide 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 equipment and associated production systems operate in a safe, and quality-oriented manner. Responsibilities include providing training and assessment support for equipment operation, set-up, changeover, and troubleshooting, providing recommendations and implementing solutions to resolve equipment and/or process problems in a timely manner, creating and revising GMP as it relates to equipment activities, supporting or own work orders, deviations, change records, corrective actions and audit observations for equipment activities. Specialists, based on scope of audit and individual skill set, will be required to support internal, client led and regulatory audits as a tour guide and/or subject matter expert through direct interaction with auditors.

This is a full-time, hourly position. The position is 2nd shift, Monday - Friday.

Catalent Pharma Solutions in Bloomington, Indiana is a state of the art, GMP manufacturing facility, providing one million sq/ft of a 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

• Has developed proficiency in a range of processes or procedures through job-related training and considerable on-the-job experience
• Completes a variety of atypical assignments, as needed
• Works within defined processes and procedures or methodologies and may help determine the appropriate approach for new assignments
• Completes work with a limited degree of supervision
• Likely to act as an informal resource for colleagues with less experience
• Required to read, understand, and follow GMP documents
• Basic understanding on Operational Excellence concepts
• Ability to read and write English
• Perform basic math skills (+,-,X,/,%, understand decimals)

The Associate Manufacturing Specialist is also responsible for:

• Making vial, syringe, and cartridge defects for required qualification sets.
• Monitor and assist with executing Knapp studies.
• Provide support to training when required
• Provide support to manufacturing on new and different defects found during manufacturing

The Candidate

• High School/GED
• 0-2 years of experience
• Manufacturing experience required
• Must be able to read and understand English-written job instructions and safety requirements

Why You Should Join Catalent

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