Job Description

A new exciting Associate Director - Data Analytics opportunity exists within the Technical Operations group in Carlow.

Reporting to the Technical Operations Commercial Process Lead, you will lead digitalisation projects in relation to manufacturing data at Carlow and align digitalisation efforts working closely with New Product Introduction, Validation and IPT Teams. You will be the Data Analytics Subject Matter Expert (SME) at the our site .

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

• Serve as data analytics engineering Subject Matter Expert (SME) at above site meetings for digitialisation projects at Carlow.
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
• Statistical data analysis to support development and commercialisation batches.
• Provide SME technical input into quality notification by authoring/reviewing/approving investigations.
• Support continuous improvement through Lean Six Sigma methodologies
• Lead and active participation in projects, system failure investigations and investigation reports,
• Contribution to Kaizen events as appropriate
• Perform root cause analysis of substandard performance, using standard tools and methods
• Implement subsequent corrective action through the change management system.
• Serve as data analytics engineering representative at above site meetings.
• Drive compliance of 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, ensuring consideration of the impact on GMP and compliance and decisions made.
• Work collaboratively to drive a safe and compliant culture in Carlow.

What skills you will need:

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
• Data analysis experience required
• Prior related work experience; in manufacturing, in a GMP Setting with strong focus on data integrity, data/statistical analysis, digitialisation initiatives
• Lean Six Sigma Methodology experience desired
• Subject Matter Expert level knowledge of data analysis visualization tools such as Power BI, Spotfire or Shiny etc. is required.
• Knowledge of manufacturing applications such as MES, DeltaV, SAP, LIMS and PI
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Sterile filling processes and equipment
• Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes one’s department supports
• Ability to effectively manage complex projects across multiple disciplines.

Our facility in Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region

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. 

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 don't 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. 

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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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