Cleaning Validation Senior Specialist

Tipperary
Permanent
Full-time

23 days ago

Job DescriptionA fantastic opportunity has arisen for a Cleaning Validation Senior Specialist.This role offers a unique chance to develop your career in a fast-paced, innovative environment, working alongside industry experts who are passionate about science, technology, and continuous improvement.This role is critical to ensuring the facility maintains a state of validation and compliance with global regulatory standards. The SME will serve as the Site Topic Lead (STL) for cleaning, supporting the introduction of new molecules, driving continuous improvement, and mentoring junior team members of the Pharm Ops Team.Bring energy, knowledge, innovation to carry out the following:

Act as the primary contact and Site Topic Lead (STL) for all cleaning-related matters.
Represent the site in global cleaning forums and initiatives.
Lead cleaning development and cleaning validation activities for new product introductions.
Ensure cleaning processes meet regulatory expectations and internal quality standards.
Maintain a validated state for all cleaning processes across the facility.
Serve as the SME during internal and external audits (e.g., HPRA, FDA).
Ensure documentation and practices are audit-ready and aligned with current Good Manufacturing Practices (cGMP).
Identify and implement innovative cleaning strategies and technologies.
Drive efficiency and effectiveness in cleaning processes.
Navigate ambiguity and provide clear direction in complex scenarios.
Coach and train junior staff and cross-functional teams on cleaning principles and practices.
Develop and deliver training materials and sessions.

What skills you will need:

Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
Experience working within pharmaceutical manufacturing environment.
Proven track record of working in cleaning roles in other pharmaceutical companies.
Experience supporting regulatory inspections and maintaining validated cleaning states.
Deep understanding of cleaning validation principles, risk assessments, and analytical methods.
Strong leadership, communication, and stakeholder management skills.
Ability to think strategically and execute tactically.
Comfortable working in a dynamic, fast-paced environment with evolving priorities.
Experience with small molecule API and drug product manufacturing including high potency.

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 applyCurrent Contingent Workers applySearch 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: Chemical Engineering, Cleanroom Processing, Cleanroom Validation, Deviation Management, Process EngineeringPreferred Skills: Cleaning ValidationsJob Posting End Date: 08/27/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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