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.

Catalent Pharma Solutions is hiring an Equipment Validation Engineer. An Equipment Validation Engineer will support the Equipment Validation Team in the drug product inspection and packaging areas of the facility.

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

• Perform Qualification activities on inspection and packaging equipment (vial and syringe labeler, cartoner, automated inspection systems for vials and syringes, thermoformer, semi-automated equipment, serialization systems)

• Interact with clients to provide validation support including but not limited to: customer product launches, new machine qualifications, new recipe implementation to support different product presentations (as needed).

• Support and provide validation oversight for capital expansion projects/build outs including packaging equipment and semi-automated and automated inspection systems

• Author validation documentation and protocols (IOQ, PQ, CCOQ, component assessments) as well as document template, validation strategies and policies

• Review facility changes and provide input on re-validation and re-qualification of equipment

• Assess risks involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables

• Be a part of a cross functional team and work closely with other supporting groups including Engineering, Manufacturing Sciences and Technology, and Operations to support and monitor validation and process improvement efforts

• Conduct validation qualifications in accordance with all applicable protocols and identify associated exceptions.

• Perform documentation review and approval including but not limited to: master batch records, component assessments, validation project plans, engineering protocols (commissioning, FAT, SAT).

THE CANDIDATE

• Bachelor’s degree or higher in STEM discipline

• Master’s degree or higher preferred

• 2-5 years of experience in Validation or related discipline

• 1 year GMP experience required or other regulated industry

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 matchand Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• On-site fitness center and wellness programs

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 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.

Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.