Process Mechanic

Eisai•Uwchlan Township, PA

25d•$34 - $44•Onsite

About The Position

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Under general direction, the Process Mechanic is responsible for monitoring, operation, performing preventive maintenance and corrective maintenance of GMP and non-GMP utilities and HVAC equipment as well as process related equipment. System operation includes, but is not limited to, plant steam, clean steam, chilled water, cooling towers, compressed air systems, and pharmaceutical grade water systems (WFI water) equipment under GMP operation. Analyzes results and may develop testing and maintenance specification on new and existing equipment. Prepare reports with recommendations for solutions to technical problems. The ability to function in a fast-paced, highly-technical environment and communicate effectively is essential to success. This position will require weekend on-call rotation and some off-hour emergency response.

Requirements

High School Diploma required, Associates Degree or equivalent experience preferred.
A minimum of 5 years working experience in a cGMP Facilities department in a FDA-regulated industry with Associates Degree, or a minimum of 7 years working experience in a cGMP Facilities department in a FDA-regulated industry with High School Diploma.
Prior experience in a GMP plant and experience with 21 CFR Part 11.
Knowledge of cGMP/EMEA and JP regulations.
Experience with inspections/audits by the FDA or other similar regulatory agencies.
Experience with CMMS software.
Working knowledge of Microsoft operating systems and proficiency in MS Office applications.
Ability to prioritize and successfully manage complex and competing projects.
Effective problem solving and reasoning skills.
Demonstrated ability to deliver effective troubleshooting solutions under tight timelines and delivery pressures while maintaining composure and strong performance.
Effective interpersonal, written and oral communication skills.

Responsibilities

Maintain GMP and non-GMP utilities related to the pilot plant and R&D facility.
Perform preventive and corrective maintenance on process related equipment. Maintains spare parts inventory for critical equipment.
Schedule preventive maintenance and corrective work orders working with user groups.
Develop and adhere to all SOPs and other GMP documentation as required.
Monitor activities of outside contractors supporting maintenance and calibration activities.
Participate in planning and process improvement activities at the departmental and inter-functional level.
Ensure adherence of operations to cGMP as well as industry safety standards and OSHA guidelines.
Interact cross-functionally with Downstream/Upstream Operations, Support Operations, Quality Assurance, Quality Control, Validation, and other internal and external functions and the R&D Facility.

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