What you need to know: Our client, a leading pharmaceutical company, is currently seeking a Validation Leadto join their team in Waterford.
This is a full-time, permanent position offering an excellent salary and benefits package.
The role will suit an experienced professional, particularly one with a background in Production Management and Engineering, Operational Leadership, Team Leadership, FMCG and Manufacturing and is looking for the opportunity to make a significant impact in a thriving organisation.
A degree in Engineering is a re-requisite.
Your new job Key duties & responsibilities: Manages a team of Product and Process Engineers to support Product Lifecycle Management of products manufactured on site.
Accountable for oversight, management, and delivery of all Validation Lifecycle components Understands and ensures compliance to evolving expectations of: Equipment and Facility C&Q, Process/Packaging validation, Cleaning validation, Continued Process validation (CPV), Analytical Method validation, and Computer System validation Collaborates across Engineering, Quality and Technical departments to ensure validation activities are completed on time and compliant to Company standards Ensures that the site can demonstrate system compliance to a regulatory auditor, (e.g., HPRA, SGS, FDA etc) Maintains site validation master plan (SVMP) As the site cleaning SME, maintains the site cleaning lifecycle process by assessing impact of new products, processes, or changes against the existing site cleaning matrix.
Coaches and develops the Technical team to ensure that cleaning validation execution demonstrates that the process produces the expected results in a reproducible manner, and that proper monitoring is in place to ensure the processes remain in a validated state of control What are we looking for?
BS degree in engineering, industrial pharmacy, chemistry, or other appropriate scientific or pharmaceutical discipline.
Minimum of 5 years of demonstrated experience in a regulated technical role, with strong experience in cleaning validation Demonstrated experience in the FMCG or Pharmaceutical industry leading the technical aspects of new product introductions, technology transfers, technical risk assessments, product control strategies, validation, and change control Apply for this job now by emailing your WORD formatted CV By applying, you are giving consent for Matrix Recruitment to contact you about this job.
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Skills: Validation FDA GMP FDA Process Validation Engineering