Catalent Pharma Solutions

Engineer – Facilities Engineering

Summary

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Engineering Department is responsible for all facilities, automation, equipment and process operations of direct and indirect equipment to the manufacturing process, and project management for any CAPEX, Continuous Improvement and Ste Strategy projects. This department manages facilities planning, construction, and renovation, including primary contact and management of architects, design engineers, contractors, and subcontractors. The Engineering Department is also responsible for managing the facility in a manner that assures uninterrupted cGMP compliance in existing manufacturing areas, as well as the research and process development areas.

The Engineer will support ongoing Facilities activities by assisting in troubleshooting mechanical problems, identifying improvements in utilities to minimize interruptions (down time) and reduce energy usage/cost, and supporting new and ongoing projects. This position will further assist in the management and planning of project budgets and schedules and provide contractor oversight.

This person will work on complex facility-related problems requiring in-depth data analysis to determine appropriate action. The Engineer is expected to have extensive ongoing communication with employees and cross-functional group managers/departments on facility-related issues.

This is a full-time on-site position, Monday – Friday 8am-4:30pm.

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 the multi-use facility, including HVAC systems, process utilities, and bio-containment systems

• Assess the current and future state of site utility system capacity and utilization and support selection and installation of manufacturing equipment.

• Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements.

• Draft SOPs for building operation, maintenance, and calibration and identify improvements and efficiencies of facility preventative maintenance.

• Provide engineering guidance and execution on facilities and equipment projects

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

• Develop standard processes to evaluate future capital projects.

• Create and maintain all aspects of equipment and facility design files. Maintain facility compliance in accordance with the site quality management system

• Author deviation investigation and change control process

• Other duties as assigned.

The Candidate

• Minimum B.S. degree in Industrial, Electrical, Mechanical, Chemical, or Civil Engineering

• Minimum 3 years’ facilities operation/engineering experience in a cGMP environment (preferably biopharmaceutical)

• Previous experience leading cross-department facility and/or site improvement projects, a plus

• Problem–solving (Lean Six Sigma) and change management methodologies consistent with establishing a culture of continuous improvement are preferred.

• Candidate needs to be highly motivated, have excellent written and verbal communication skills, and critical thinking and problem-solving skills.

• Ability to use Excel, Word, and other office systems.

• Ability to cross-train on techniques across multiple groups and is proficient in the operation and troubleshooting of a wide variety of instrumentation and data systems.

• Understanding and adherence to applicable regulatory authority and guidelines

Physical Requirements

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.

• Occasional stooping, kneeling, crouching, bending, carrying, grasping.

• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.

• Must comply with EHS responsibilities for the position.

• Working conditions will be Heating Ventilation and Air Conditioned controlled.

• Ability to operate within a clean room environment as needed.

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 (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) .