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 hiring a Senior Process Engineer responsible for supporting cGMP operations and becoming an expert in their field; knowledgeable of automation/controls associated with manufacturing and support equipment; able to seamlessly work cross-functionally to provide unified engineering support to the manufacturing group. Works as an industry expert to create design specifications, P&ID drawings, general arrangement drawings, user requirements, functional specifications, and automation control strategies. Provides technical solutions to complex problems by relying upon their experience and/or seeking recommendations from industry experts. Understands and applies the concepts of the manufacturing area supported. Develops processes to minimize risks and is very familiar with change management in a cGMP environment.

The Senior Process Engineer will support ongoing Drug Substance manufacturing activities by being system owner of process equipment, including large and critical bioprocessing assets. They will be assisting in troubleshooting complex mechanical problems, identifying improvements in process equipment to enhance safety, prevent quality and compliance issues, minimize downtime, and reduce operational costs. They will also support new and ongoing capital expenditure (capex) projects by managing and planning project schedules and budgets as well as providing contractor oversight. This position will assist in identifying, tracking, forecasting, and implementing capex projects by working with site leadership and departmental end-users to identify the correct project parameters and requirements.

Catalent in Bloomington, Indiana is a state-of-the-art, cGMP manufacturing facility, providing one million sqft 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:

• Support Drug Substance manufacturing and engineering operations and act as subject matter expert within their scope of responsibility

• Has knowledge of the principles, theories, and concepts applicable to a wide range of process engineering work

• Applies technical and functional knowledge on a broad range of difficult problems to enable department/group/team to meet goals

• Recommend improvements to meet OSHA, ISPE, and FDA guidelines as well as industry best practices

• Maintain project compliance in accordance with the site quality management system

• Review and execute changes to validated production systems through the change control program

• Assist in responding to customer and regulatory audit observations and corrective actions

• Create and maintain all aspects of equipment design files

• Provide engineering guidance and execution on equipment and automation projects

• Identify and implement improvement opportunities for established production systems

• Guide the specification and selection of manufacturing equipment to support site process needs

• Develop standard processes to evaluate future capital projects

• Contribute to the creation of maintenance and calibration procedures and update existing procedures to match best practices and lessons learned

• Perform hands-on activities as needed to help troubleshoot problems and support staff

• Evaluate systems for obsoletion and updates to meet future operations

• Competent at risk mitigation for function

• Collaborate significantly with cross-functional groups including Manufacturing, Validation, Quality Assurance, Facilities

• Provide direction and mentor other team members

• Provide technical assistance and training for personnel

• Other duties as assigned

The Candidate:

• Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline, required

• Master’s degree, preferred

• PE / Registered Engineer in training, preferred

• OSHA/IOSH/NeBOSH Certification or equivalent, preferred

• 5+ years Project Engineering relevant experience

• 2+ years in a regulated industry (Life Sciences, preferred)

• 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

• 152 hours 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 match and Paid Time Off accrual

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

• Tuition Reimbursement

• 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 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) .