Spclst, Engineering

Job Description

A fantastic opportunity has arisen for an Engineering Specialist (Validation). This opportunity is for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidate will support the Cleaning Validation & Cleaning Recovery Teams.  

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

•    Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
•    Design/Author/Review/Approve/Execute Execution/development of change controls.
•    Resolving technical issues encountered during study execution.
•    Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
•    Technical input into quality notification by authoring/reviewing/approving investigations.
•    Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
•    Support continuous improvement through Lean Six Sigma methodologies.
•    Serve as validation representative for cross functional projects and represent the validation team at global technical forums
•    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.
•    Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance
•    Supporting regulatory audits and submissions as required.
•    Work collaboratively to drive a safe and compliant culture on site.
•    May be required to perform other duties as assigned.

What skills you will need: 

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

•    Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
•    Experience in the validation of Tank CIP & Parts Washers for in-process components.
•    Experience in cleaning recovery studies using TOC and swab methods.
•    Exception / Deviation Management and Change Control.
•    Demonstratable experience of leading technical related projects.
•    Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
•    Evidence of continuous professional development is desirable.
•    Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
•    Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
•    Report, standards, policy writing skills required.
•    Equipment and process validation.
•    Sterile Fill-Finish processes and equipment.
•    Proficiency in Microsoft Office and job-related computer applications required
•    Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
•    Equipment Periodic Validation
•    Equipment Validation Lifecycle
•    Project Management Skills/Qualification
•    Autoclave/SIP Sterilisation Validation
•    Dry Heat Sterilisation
•    Isolator VHP/HVAC Qualification
•    Controlled Temperature Units/Equipment Qualification
•    Vial and Syringe Processing Technologies

 
The 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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing 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 or click on the link to find out more about our hybrid working model 

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. 

Employee Status:

Relocation:

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