Sr. Engineer – Sterile Process/Capital Project Support-CHE002167
Merck & Co. Inc., established in 1891, is a global research-driven pharmaceutical company dedicated to putting patients first.
Join us and experience our culture first-hand – one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Sr. Engineer will support the Primaxin process. Primaxin is an antibiotic used to treat bacterial infection. There are two areas of the process in which this position may support. Primaxin is produced in a bulk sterile powder form and it is then filled/finished into vials. Merck’s Elkton, Virginia facility is searching for individuals with prior chemical or mechanical process engineering background and education to join this team in both a process support role as well as a capital project capacity to support the existing process as well as a new building all related to the Primaxin product.
Primary activities include (but are not limited to):
* Develop, design, construct, validate or operate aseptic processes and facilities using new or existing technologies for a sterile environment.
* Provide leadership for troubleshooting and efficiently resolving manufacturing problems. Effectively develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply of sterile products.
* Development of sound scientific justification for planned material and process and equipment changes.
* Maintenance of working relationships with MMD (Merck Manufacturing Division) sites and with architectural and engineering firms, construction management firms, outside vendors, and state and federal agencies (FDA/OSHA/EPA) with whom Merck interfaces.
* Analysis of current and proposed safety/environmental and drug product regulatory requirements and determination of the applicability and impact on Merck operations.
* Initiating and implementing new, creative ideas to reduce costs and improve productivity.
* Prepares and/or provides review and guidance for documentation preparation, maintenance, and review including SOP’s, regulatory filings, process descriptions, atypical process reports, and change requests.
* Ability to thoroughly investigate processing abnormalities and drive to root cause analysis, clearly document the results of the investigation and implement appropriate corrective actions.
* Sr. Engineers may be put in a position of leadership in the areas of project and investigation management, supervisory experience, and experience with change management.
* Bachelor of Science in Chemical Engineering, Mechanical Engineering, or Biomedical Engineering
* 5 years experience in a process engineering support or capital project engineering role supporting an FDA regulated process
* Experience with a sterile/aseptic process
* Experience with a pharmaceutical manufacturing process
Consistently cited as a great place to work, we discover, develop, manufacture and market a wide range of vaccines and medicines to address unmet medical needs. Each of our employees is joined by an extraordinary sense of purpose – bringing Merck’s finest achievements to people around the world.
We offer an excellent salary and an industry-ranked benefits program, including tuition reimbursement, work-life balance initiatives and developmental programs at all levels. Merck’s retirement package includes a pension plan and one of the best 401(k) plans in the nation.
To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition #CHE002167. Merck is an equal opportunity employer, M/F/D/V – proudly embracing diversity in all of its manifestations.
Primary Location: US-VA-Elkton
Employee Status: Regular
Number of Openings :1
Shift (if applicable): N/A
Please click here to apply