4862 Engineer III
In this role, you will be primarily accountable for ensuring your assigned equipment/systems are fit for purpose and ready for use by manufacturing.
You will also be responsible for investigating and assessing unplanned equipment related events, managing planned equipment changes, and executing/supporting small projects.
You will coordinate with a cross functional team including Manufacturing, Process Engineering, Maintenance, System Owners, Automation, SHE, and Quality Assurance.
You will use your functional partnerships, project leadership skills, and your advanced understanding of GMP systems to identify and solve complex problems, influence decision makers, and deliver results.
The candidate should have a technical understanding of autoclaves including experience with the mechanical components (e.g. vacuum pumps, valves, controls, etc.) and knowledge of the sterilization process.
The ideal candidate would also be qualified to support parts washers, clean in place (CIP) skids, bioreactors, centrifuges, and/or process analytical systems.
The candidate will work with limited direction to complete assigned objectives to improve system uptime by preventing equipment failures.
The candidate is not required to provide on-call, after hour support, but that candidate would be considered for this depending on their qualifications, availability, and experience.
The hiring manager is the Sr Manager of Upstream Frontline Engineering in the Facilities and Engineering Department has responsibility for both the upstream equipment and the production services equipment including the autoclaves.
The Manufacturing Engineers/Specialists on this Frontline Engineering Team are process and equipment subject matter experts and they closely support manufacturing operations.
Education and Industry Experience:
B.S, M.S, Ph.D or advanced degree in engineering preferred.
At least 6 years of experience in the industry and/or academia (including advanced studies).
Sound knowledge of current Good Manufacturing Practices (cGMPs) as they apply to biopharmaceutical manufacturing facilities or equivalent regulation.
Familiarity with reliability engineering principles and techniques preferred.
General knowledge of bio-tech related unit operations.
Experience with automated systems, trend analysis, and troubleshooting.
Must have excellent interpersonal, communication, and teamwork skills.
Strong verbal and written communication skills and the ability to influence at all levels.
Able to think strategically and translate strategies into actionable plans.
Takes responsibility, drives results, and achieves expected outcomes.
Flexibility in problem solving and work hours to meet business objectives.
Uses extensive operational knowledge and cross-functional experience to solve problems.
Performs work under limited supervision; establishes own work priorities and timelines.
Provides guidance and coordinates the activities of team members as needed.
Exercises independent judgment and discretion in their assigned areas of responsibility.
Represents our organization as primary contact for initiatives and projects.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.