Process Mechanic

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.

Essential Functions

• 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.

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.

• Other Information (, Physical Requirements, On-Call Schedules, etc.)

• Limited handling of laboratory equipment, chemicals, and biological materials

• While performing the duties of this job the employee is frequently required to stand, walk, use hands to fingers, handle or feel objects, tools, or controls; reach with hands or arms; climb or balance; stoop, kneel, crouch, or crawl; and talk and hear. The employee is occasionally required to sit.

• The employee must frequently lift and or move up to 50 pounds.

• This position will require weekend on-call rotation and some off-hour emergency response.

• Typical onsite hours are 7:00 a.m. -3:30 p.m. M-F andon-call hours are typically 1 weekend a month, between Friday night 11:00 p.m. to Sunday night 11:00 p.m. Hours may be subject to change based on business needs.

Eisai Salary Transparency Language:

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

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