Spclst, Process Engineering (MS&T) - Upstream or Downstream

Job Description

Our Biotech facility in Dublin began construction in 2018 and has progressed at an impressive rate since then. The site plays a pivotal role in the manufacture of our Company’s biologics-based medicines, including immuno-oncology, and it has expanded our Company’s current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021.

We have a great opportunity for a Specialist MS&T to join the team; we welcome candidates with either upstream or downstream process engineering experience. The successful candidate will be placed within the upstream or downstream team based on their relevant experience, technical expertise, and organizational requirements.

The Specialist MS&T (process engineering & NPI) supports sustaining activities, manages and drives process qualification and validation related activities. Supports the design, construction and qualification of upstream & downstream equipment, NPI/technology transfer and commercialization at our Biotech site.

Ensures that MS&T team objectives are effectively achieved, consistent with our company and requirements to ensure compliance, safety and reliable supply to our customers.

Bring energy, knowledge, innovation to carry out the following:

• Ensure compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.

• Support the execution of development and PPQ batches, change control management and implementation.

• Assist in and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs.

• Participate in audits and inspections.

• Support continuous improvement through Lean Six Sigma methodologies.

• Support various site initiatives to improve compliance status and overall operational efficiency of the site.

• Support the experimental design, execution, data analysis and interpretation.

• Interpret trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.

• Author and review of batch documentation, technical reports and global regulatory submissions.

• Support multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.

• Apply Lean Six Sigma tools by

• • Securing continuity of an appropriate LSS/CEM level of knowledge.

• • Facilitating problem solving & risk assessment (FMEA) projects/meetings.

• • Making problems visible and strive for continuous improvement.

• Serve as a key member during internal audits and external inspections/audits.

• Lead and support various MS&T organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

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

• Degree in (Bio) Chemistry, Process Technology, Biotechnology, Engineering or

• comparable.

• Experience with upstream cell culture and/or downstream purification of biological

• molecules.

• Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics is preferred but not essential

• Experience in change management, deviations and CAPAs management (desirable)

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 committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Required Skills:

Preferred Skills:

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.

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Relocation:

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