Senior Process Engineer - Equipment

Catalent • Baltimore, MD

274d • $93,280 - $128,260

About The Position

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 Cell & Gene Therapy is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a Catalent employee, you will actively contribute to the delivery of our services and products to our customers and their patients. Catalent Pharma Solutions in Harmans, MD is hiring a Senior Engineer, Equipment who is responsible for aspects of introducing a new suite of biopharmaceutical products at our development and manufacturing sites. The majority of process will be liquid formulations manufactured under single-use production concept, in a cleanroom environment. This role is involved in onboarding new process equipment, working closely on the ground with production and development personnel, preparing and executing commissioning and qualification protocols, organizing the production process equipment layout, and coordinating with other departments to ensure the validated status of process equipment. The project will require a full-time engineer and is a tremendous opportunity for an ambitious hands-on engineer to become a core team player in a team working for an expanding CDMO. All work to be carried out in compliance with cGMP and company standard operating procedures and policies. This is a full-time, salaried role. This is onsite. The core hours are 8:00AM - 5:00PM.

Requirements

• Bachelor of Science in Engineering, chemical or mechanical engineering required.
• 4+ years related work experience (GMP / Bio-Pharma maintenance/ engineering).
• Demonstrated abilities in mechanical/electrical design, repairs and maintenance.
• Understand and apply engineering principles to troubleshooting and repairing bioprocess equipment and instrumentation.
• Experience with filling of drug product and familiarity with aseptic filling equipment including isolator technology.
• Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing.
• Knowledge of documentation practices associated with cGMP operations.

Nice To Haves

• Knowledge of biopharmaceutical equipment design, construction, operation, qualification, and maintenance.

Responsibilities

• Analyze and develop engineering solutions to maintenance, continuous improvement, quality and safety initiatives, and failure investigations for manufacturing equipment/systems, instrumentation, and filling equipment.
• Work independently on assigned projects and collaboratively in a multi-functional team environment supporting day-to-day manufacturing schedules and operations.
• Hands-on work troubleshooting and repairing bioprocess equipment.
• Work with Fill/finish process scale-up and technology transfer including the use of gap analysis, root cause analysis, and risk assessment tools.
• Work within Computerized Maintenance Management Systems (CMMS) to complete tasks.
• Lead engineering projects from start to finish including documentation, scheduling, overseeing maintenance mechanics and/or contractors.
• Work within manual and electronic Quality Systems to implement equipment, facility, and automation change control, document revisions, and conduct equipment/system/instrumentation failure investigations.
• Maintain engineering drawings and equipment history files.

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Positive working environment focusing on continually improving processes to remain innovative.
• Potential for career growth on an expanding team.
• 152 Hours + 8 paid holidays.
• Several Employee Resource Groups focusing on D&I.
• Dynamic, fast-paced work environment.
• Community engagement and green initiatives.
• Generous 401K match.
• Company match on donations to organizations.
• Medical, dental and vision benefits effective day one of employment.
• Tuition Reimbursement.
• WellHub program to promote overall physical wellness.
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree