Senior Engineering Technician

Location: Harmans

Senior Engineering Technician

Position Summary:

* Work Schedule:

7pm-7am, Thursday - Saturday and every other Wednesday

* 100% on-site

Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD-just minutes from BWI Airport-features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products.

We are currently seeking a Senior Engineering Technician to provide technical support to GMP manufacturing/testing operations for Phase I/II bulk, Phase III and finished biologics in our multi-product facility in Harmans, MD.

The Senior Engineering Technician will be responsible for the overall facilities including executing the preventative maintenance, repairs, and installation of process equipment.

The Engineering Technician will report to the Supervisor, Engineering Technician.

The Role:

* Analyze and develop engineering solutions to maintenance, continuous improvement, quality and safety initiatives, and failure investigations for manufacturing equipment/systems and instrumentation.

* Work independently on assigned projects and collaboratively in a multi-functional team environment supporting day-to-day manufacturing schedules and operations.

* Will engage in hands-on work troubleshooting and lead the repairing of bioprocess equipment. Equipment includes fermenters, bioreactors, centrifuges, tangential flow filtration systems, chromatography systems, incubators, BSCs, controlled temperature units, and laboratory equipment.

* Work within Computerized Maintenance Management Systems (CMMS) to complete preventive and responsive maintenance work orders.

* Work within manual and electronic engineering documentation systems to maintain engineering drawings and equipment history files.

* Work with subcontractors and vendors as needed on equipment preventive maintenance, calibrations, and repairs.

* Assist in maintaining PM programs for the bioprocess equipment and instrumentation. This includes generating PM SOPs/records, establishing PM frequencies, specifying spare parts and recommending/maintaining inventory levels.

* Work with equipment vendors and Catalent's purchasing department to quote/purchase/procure equipment parts and instrumentation.

* Develop job aids, work instructions, and troubleshooting guides for performing routine maintenance and repairs. Will be responsible for generating and updating documentation throughout the life cycle of the equipment.

* Work in clean rooms that requires full gowning (tyvek coverall, gloves, hair cover, shoe covers.)

* Other duties as assigned

The Candidate:

* High School Diploma required;
Associates/Bachelors degree preferred.

* A minimum of 5 years of related work experience, specifically in GMP / Bio-Pharma maintenance and/or engineering experience;
Clean room experience or experience in a similar GMP / FDA regulated industry.

* Must demonstrate abilities in mechanical/electrical repairs and maintenance.

* Automation and controls operation, repairs and maintenance are preferred.

* Requires basic math and computer skills (eg. Word and Excel) and must be able to clearly communicate (verbal, written).

* Must have the ability to lift/carry 40 lbs. and to work on ladders/step stools.

* Requires working extended periods on his/her feet in a manufacturing environment and must follow all Catalent's Safety and Quality procedures and practices.

The anticipated hourly rate for this position in Maryland is $38.46 - $43.26 plus shift differential and annual bonus, when eligible. The final hourly rate 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.

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