Catalent Pharma Solutions

Senior Project Engineer

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.

Greendale, IN is part of the Wellness Group within Catalent, as well as the Softgel and Oral Technologies (SOT Business Unit). This Catalent manufacturing operation specializes in gummy manufacturing. On site, we have a state-of-the-art Mogul unit for manufacturing gummies, a highspeed bottling process, and a pouching operation.

Sr. Project Engineer is responsible for developing, leading, and driving Sr. projects onsite from production equipment to building infrastructure systems in a nutraceutical manufacturing environment. The Sr. Project Engineer will routinely work cross functionally to develop and implement projects-interfacing with process engineers, production, quality, safety, maintenance, and the site leadership team.

Your talents, ideas, and passion are essential to our mission: to help people 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

• Evaluate and prioritize projects to improve site performance, efficiency, safety, quality and cost. Develop and communicate project budgets, schedules, and specifications.

• Collaborate with key stakeholders, process and packaging engineers, production, quality groups, and IT to identify all project requirements. Create and manage RFP process for vendor selection and procurement.

• Develop required documentation (user requirements, design specs, etc).

• Specify and select process, utility, and facility equipment to support site needs.

• Evaluate and develop project business cases. Lead teams of architects, engineers, and GC’s to design and implement project concept.

• Manage all contractors and processes to ensure compliance:Corporate Safety Guideline, cGMP requirement,Global Engineering Sr. Project Standards andCost, scope, and schedule adherence.

• Track, manage, and report out project updates to management, stakeholders and executive management.

• Maintain all documentation through project from design/specification to full qualification. Assist in writing and executing validation protocols. Finalize all documentation and change control closure.

• Provides other duties as directed by engineering management.

The Candidate

• Bachelor of Science in Engineering, or related degree

• Minimum 8 years of experience in a manufacturing environment

• Experience with project management in pharmaceutical, food, or biotechnology industry preferred

• Understanding of cGMP and FDA requirements for food and beverage

• Working knowledge of 21 CFR Part 11 is essential

• Sustaining static postures. Sustained sitting at desk, workstation, lab or other environment. Static stance/standing as required. Infrequent lifting overhead reaching less than or equal to 15 lbs with the ability to potentially be able to lift up to 35 lbs and push/pull 40 lbs.

Why You Should Join Catalent

· Spearhead exciting and innovative projects

· Fast-paced, dynamic environment

· High visibility to members at all levels of the organization

· 152 hours of PTO + 8 paid holidays

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 (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .