Spclst, Engineering

Job Description

Within our Company in Ireland we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. Were always looking to make a difference for people patients and communities from our Company in Ireland to the world.

Our Commitment to Ireland:

Ireland is one of the Irelands leading healthcare companies having first established here over 50 years ago. We have a dynamic and diverse team of over 3000 employees currently working across seven sites in Ballydine Co Tipperary Brinny Co Cork Dunboyne Co Meath Carlow and Dublin where in addition operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations our Irish sites manufacture many of our Companys top products helping save and enhance lives in over 140 countries around the world

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 Companys biologics-based medicines including immuno-oncology and it has expanded our Companys current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021.

An exciting opportunity has arisen within The Specialist MS&T (AnalyticalandDownstream Process Sciences) delivers a range of technical support to theBiologicsDrug Substance Business: supportingtechnology transfers process characterisation andtechnical investigations within the Integrated Process Team supporting significant projects in the MS&T laboratory while creating an inclusive culture that energizes a Safety First Quality Always with a continuous improvement mindset.

Bring energy knowledge innovation to carry out the following:

• Provide analytical testing support to the Process Sciences Team as required.

• Support analytical activities in the MS&T laboratory.

• Provide technical leadership for analytical projects including experimental design execution data analysis and interpretation.

• Develop transfer and qualify assays.

• Establish and validate analytical procedures.

• Assist in designing supporting and executing Downstream Process Sciences technical projects (e.g. UFDF Chromatography filtration) at small scale to support large-scale manufacturing.

• Execute experimental design data analysis and interpretation to resolve technical projects and complex investigations/deviations.

• Support train and mentor the Process Sciences team during small scale model run execution including buffer preparation lab-scale equipment set up run execution sampling and data analysis.

• Author and review standard operating procedures (SOPs) protocols and reports as required.

• Identify and support continuous improvement opportunities through Lean Six Sigma methodologies.

• Lead process improvement technical problem-solving and troubleshooting with end-toend product focus.

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

• Support alignment and knowledge exchange with departments development organizations other commercial nodes and external manufacturing partners

What skills you will need:

• Bachelors degree in Biological Sciences Chemistry Chemical Engineering or Biological Engineering with 2 years of experience.

• Experience leading technical related projects.

• Experience in either Analysis of Biological Products or Downstream Drug Substance manufacturing process development process characterization studies downstream technology and/or process modeling.

• Experience in either Analytical Science including use of HPLC/UPLC CIEF and Mass Spectrometry or designing and executing experimental programs in the laboratory including small-scale lab experience (e.g. AKTA Avant chromatography UFDF NFF).

• Working knowledge of statistical methods for DOE design and data analysis (e.g. JMP or Design Expert software).

• Technical writing skills.

• Data Analysis Estimation and Planning Chromatography HPLC/UPLC Titration assay Tecan DOE Process Design Process Improvements Project Planning Regulatory Compliance Root Cause Analysis (RCA) Six Sigma Standard Operating Procedure (SOP) Technical Support Technical Writing Technology Transfer.

• Experience with technology transfer regulatory filing and commercial drug substance manufacturing of biologics.

• Evidence of continuous professional development.

• Demonstrated leadership and change management skills with a continuous improvement focus.

• Proven track record of delivering high performance through development and coaching of a team.

• Strong collaboration to promote knowledge sharing and implementation of best practices across the site.

• Desire to continuously learn improve and develop.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.

As an equal opportunity employer we are proud to be a company that embraces the value of bringing diverse talented and committed people together.

Please dont hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

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

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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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