Validation Specialist

Job Description

A fantastic opportunity has arisen for a Validation Specialist. The successful candidate will take a lead on utilising the latest innovations in technology. The role is based at our Large-Scale Mammalian-Based Drug Substance Facility in Dublin which is a significant supplier of drug substance for one of our key treatments and will also be critical in the future supply of new biotechnology products to our global network.

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

• Support the site validation activities across a number of workstreams.
• Develop and maintain the site Validation Master Plan.
• Drive completion of cleaning and sanitisation cycle validation activities.
• Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and subsequent revalidation.
• Develop post OQ documentation in line with company and regulatory requirements.
• Author and review standard operating procedures and technical reports.
• Support global regulatory submissions as needed.
• Apply Lean Six Sigma through continuity of an appropriate LSS/CEM level of knowledge.
• Facilitate problem solving & risk assessment projects/meetings.
• Making problems visible and strive for continuous improvement.
• Serve as a key member during internal audits and external inspections/audits.
• Support alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
• Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
• Represent the site in internal collaborations through our Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
• Keep up to date with scientific and technical developments.
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

What skills you will need:

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

• 3 years direct experience with a pharmaceutical or biotechnology company with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience).
• Prior experience in Cleaning Validation, Temperature Mapping activities, and qualification of Partswashers and/or Autoclaves.
• 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.
• Technical operations/support experience in the drug substance manufacture of biological molecules at the pilot- and/or commercial-scale.
• Prior experience in drug substance, process performance qualification and validation, site readiness, batch record reviews, and authoring regulatory CTD sections.

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.

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/11/2025

*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.

Requisition ID:R342444