Description:
The Role
- 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 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. Equipment includes fermenters, bioreactors, centrifuges, chromatography systems, incubators, BSCs, controlled temperature units, fillers, isolators and laboratory equipment;
- Hands-on work with Fill/finish process scale-up and technology transfer including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.);
- Work within Computerized Maintenance Management Systems (CMMS) to complete preventive and responsive maintenance work orders;
- Work within manual and electronic Quality Systems to implement equipment, facility, and automation change control, document revisions, and conduct equipment/system/instrumentation failure investigations;
- Work within manual and electronic Facilities Engineering documentation systems to maintain engineering drawings and equipment history files;
- Lead engineering projects from start to finish including documentation, scheduling, overseeing maintenance mechanics and/or contractors;
- All other duties as assigned;
The Candidate
- Bachelor of Science in Engineering required (Chemical or mechanical engineering preferred);
- 10+ years related work experience required (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 cGMP operations (SOPs, batch records, calibration and maintenance records, equipment logbooks, change control, etc.);
- Knowledge of biopharmaceutical equipment design, construction, operation, qualification, and maintenance;
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
The Pay
- The anticipated salary range for this position in Maryland is $135,000 to $180,000. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states
Why you should join Catalent:
- 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 within an organization dedicated to preserving and bettering lives
- 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 – Let us help you finish your degree or start a new degree!
- WellHub program to promote overall physical wellness
- Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories