Pharmaceutical Validation Specialist

6 days ago

Carlow, Ireland beBeeValidation Full time €85,000 - €110,000

Job Opportunity:

We are recruiting for a position with a multinational organization.

This is an excellent opportunity to join a company renowned for its excellence in the industry.

Duties and Responsibilities:

  • Develop and qualify cleaning cycles, execute equipment qualification.
  • Coordinate validation strategies, write protocols, submit samples, analyze test results, prepare technical reports.
  • Execute routine business activities such as periodic reviews, cleaning reviews, CAPAs, deviations, change control, risk assessments.
  • Support commissioning by reviewing documents.
  • Ensure documentation complies with standards.
  • Participate in cross-functional problem-solving teams for troubleshooting and investigations.
  • Prepare technical reports, perform statistical analysis of data.
  • Adhere to regulatory guidelines.
  • Represent the team on project teams.
  • Provide technical input, present as SME during regulatory inspections.
  • Adhere to highest standards for Compliance (Quality and Safety).
  • Ensure compliance with site EHS policy, cGMP and other business regulations.
  • Support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
  • Participate and comply with QMS requirements.

Requirements:

  • Experience as a validation specialist in a pharmaceutical or highly regulated environment.
  • Bachelor's Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or related field.
  • Experience in C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
  • Working knowledge of GxP systems associated with this role, including GLIMS and eVAL, electronic batch records.

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