Downstream Manufacturing Engineer

Merck Gruppe - MSD Sharp & Dohme; Swords; On-site; CAD 70,000 - 90,000; Full time

Job summary

An exciting opportunity for a Downstream Manufacturing Engineer at a leading healthcare company. The role involves ensuring operational readiness for large-scale production and driving continuous improvement in downstream operations. Ideal candidates will have a Level 8 Degree in Science or Engineering and relevant industry experience.

Qualifications

• At least 2 years’ experience in the pharmaceutical industry.
• Experience in Drug Substance and Downstream Operations.

Responsibilities

• Ensure operational readiness for large-scale production.
• Drive continuous improvement projects in Downstream Operations.
• Lead Root Cause Analysis for safety and quality events.

Skills

Leadership

Change Management

Continuous Improvement

Education

Level 8 Degree in Science

Engineering

Tools

MES

SAP

Delta V

Job description

Job Description

An amazing opportunity has arisen for a Downstream Manufacturing Engineer. The role is a key technical subject matter expert role with accountability to ensure the facility is operationally ready for commercial large-scale production of Drug Substance as per start-up schedule and will report to the Downstream Operations Support Lead.

What you will do:

• Bring energy, knowledge, innovation and leadership to carry out the following:
• Work as a key team member within the Downstream (DS) Integrated Process Team (IPT) to ensure on-time delivery of the production schedule while maintaining alignment with site safety and quality standards.
• Provide oversight and issue resolution on material management within the BDS, ensuring quality and delivery metrics related to material management are always maintained.
• Complete downtime analysis and trending for respective area and drive improvement projects in conjunction with the technical operations team.
• Provide oversight on day-to-day production quality metrics ensuring on-time documentation closure, line clearance and material management as per area SOPs.
• Drive continuous improvement projects related to schedule, equipment and delivery capability within the DS IPT.
• Act as a link between the shift operations team and days team, ensuring standardisation and integration between all IPT teams.
• Provide process and operational expertise on a range of topics, including but not limited to introduction of new equipment and processes.
• Provide tactical support for reliability equipment initiatives.
• Support audit readiness in the BDS and drive a permanent audit readiness culture within the team.
• Lead Root Cause Analysis (RCA) sessions for both safety and quality related events, driving actions to closure with appropriate corrective/preventive measures.
• Drive MPS standards within the area and ensure team alignment on same.
• Lead/support area change controls, CAPAs, QSAT actions as relevant per work stream as well as completing documentation updates as required.
• Manage and update BOMs per assigned workstream.
• Provide ongoing coaching and support to cross functional team members, to share process and operational best practices.
• Demonstrate strong system capabilities such as MES, SAP, Delta V.

In order to excel in this role, you will more than likely have:

• Level 8 Degree in Science, Engineering or other relevant disciplines.
• At least 2 years’ experience in the pharmaceutical industry (preferably with experience in Drug Substance, Downstream Operations).
• Demonstrated leadership and change management skills with a continuous improvement focus.

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Preferred Skills:

Job Posting End Date:

05/15/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R344908