Principal Automation Engineer, Biopharmaceutical Development

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

* Provide high level technical assistance to site operating groups through investigations, controls systems assessments and design support. Proactively look for and recommend improvements to equipment operation, site processes and procedures.

* Maintain automation systems on Exton, PA site through PM activities. Perform alarm reviews to provide supporting evidence for critical alarms as well as to alleviate nuisance alarms. Support Validation in their qualification work as well as in validation maintenance activities. Maintain all automated system design documentation as well as all building controlled drawings.

* Lead and execute multi-disciplined projects of high-level complexity from inception to project completion in support of site operations, insuring company standards, operational requirements and business needs. Specify, design and install control systems in direct support of Pilot Plant operations. Lead, coordinate and oversee development of projects design documents. Coordinate and review work of all design and deliverables (drawings, specification, etc.) Lead team review of designs and document decisions. Responsible for the design of new applications. Prepare small to large- scale project estimates for control/automation design, equipment, installation, labor, materials, and other related costs. Prepare project forecasts and schedules and track costs.

* Work with site technical and operations personal to ensure that business needs and regulatory requirements are met by the control systems.

* Ensure adherence of operations to cGMP, ICH, and JP guidelines as well as industry safety standards and OSHA guidelines.

Requirements

* Bachelor degree in engineering preferred.

* At least 10 years of instrument/automation experience in the Biologics or Pharmaceutical industry required.

* Prior experience in GMP plant experience with 21 CFR Part 11 is required.

* Prior experience in the design, programming, start up, and troubleshooting of process control instrumentation including PLC and SCADA systems required.

* Allen-Bradley experience required. Wonderware experience a plus.

* Working knowledge of Microsoft operating systems is required.

* General programming knowledge to assist in integrating systems preferred

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://us.eisai.com/careers-at-eisai/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:

Right To Work

E-Verify Participation