Validation Specialist Sterilisation
Validation Specialist Sterilisation
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Job Description
Job Description
A new and exciting opportunity has come for a Validation Senior Engineering Specialist(s) on our Carlow Site with Technical Operations. You will be responsible for:
- Leadership of validation activities within the Sterilisation qualification team and across other validation teams.
- Maintaining 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.
- 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 in Carlow.
What you will do:
Bring energy knowledge innovation and leadership to carry out the following:
The successful candidate will be involved in Cycle Development Performance Qualification activities and Periodic Revalidation on the Carlow site included but not limited to the following:
- Planning scheduling and oversight of Periodic Revalidation & Performance Qualification studies.
- Responsible for setting and delivery of validation strategies.
- Lead and supports complex & critical investigations associated with validation and commercial activities.
- Co-ordinate multiple complex projects in parallel including but not limited New Product Introductions Process Improvements and Investigations.
- Execution of Periodic Revalidation Cycle Development & Performance Qualification studies as required.
- Technical review and approval of Periodic Revalidation Cycle Development & Performance Qualification protocols & reports.
- Authoring and reviewing standard operating procedures and technical reports.
- Engage in the early stages of projects.
- Act as validation SME on the equipment within the area assigned
- Serving as a key member during internal audits and external inspections/audits.
- Implementing the requirements as outlined in the site & project Validation Master Plan(s) and periodic revalidation plan.
- Supporting regulatory submissions.
- Support continuous improvement through Lean Six Sigma methodologies.
- Make problems visible and strive for continuous improvement.
- Lead and promote various organizational initiatives as needed (examples include EHS workload forecasting work standardisation etc).
- Providing technical and validation oversight to process design and project delivery teams.
- Represent the site in internal collaborations through Manufacturing Division Communities of Practice (CoP) for Validation to include imparting of best practices in Validation and investigation activities.
- Keep up to date with scientific and technical developments best practices and attend seminars.
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
- Within the role you will be acting as a validation engineer reporting within the Validation Engineering Team.
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 / Computer / Chemical sciences or applied Technical / Engineering qualification the successful candidate will also have a proven track record in delivering excellence.
- A minimum of 4-5 years directly related experience in academia pharmaceutical or biotechnology industry along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
- SME in Sterilisation Validation for autoclaves and SIP.
- Proven history of leadership skills within current and previous roles.
- Knowledge of process monitoring systems automation systems (DeltaV) operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
- Experience of coaching mentoring and leading a team in the validation department in the past is desirable
- Prior experience in drug product processing equipment PQ Process Performance Qualification and Validation site readiness authoring documents subject to regulatory inspection.
- Knowledge of regulatory/code requirements to Irish European and International Codes Standards and Practices
- Analysing and interpreting complex data
- Excellent communication presentation and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team orientated manner
- Experience in working in other validation areas such CTU Isolator and Filling Lines Cleaning Validation Ancillary Qualification (Filters CCI Shipping) is considered advantageous but not mandatory.
At our company 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 Ireland to the world.
Our Commitment to Ireland:
Our Company 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 the companys top products helping save and enhance lives in over 140 countries around the world.
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 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 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 worlds 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 worlds 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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Cleaning Validations Engineering Standards Equipment Qualification Instrument Sterilization Interdisciplinary Collaboration Managing Change Requests Manufacturing Processes Process Improvements Project Management Project Management Software (PMS) Project Planning Regulatory Compliance Risk Assessments Root Cause Analysis (RCA) Standard Operating Procedure (SOP) Sterile Filling Sterilization Sterilization Procedures Sterilization Techniques Sterilizing Equipment Technical Support Validation Activities Validation Processes Validation ProtocolsPreferred Skills:
Change Controls ManufacturingJob Posting End Date:
07/30/2025*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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
