Senior Validation Engineer

1 week ago

Singapore beBeevalidation Full time $120,000 - $180,000
Validation Specialist

The role of a Validation Specialist is to ensure that all systems, equipment and processes are validated and compliant with regulatory requirements.

  • Main Responsibilities:
  • Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities, facilities and processes.
  • Develop validation protocols and reports that fulfil regulatory requirements and industry best practices.
  • Assist in developing User Requirements Specification documents.
  • Prepare design review and design qualification documents at the initial design stage to align with specifications.
  • Generate protocols and execute field work related to Commissioning (FAT, SAT), Installation & Operational Qualification (IOQ).
  • Prepare and execute FMEA and validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation and Transport Qualification, as required.
  • Complete assigned CQV tasks according to planned schedule, budget, safety and engineering standards.
  • Coordinate with internal teams (manufacturing, engineering, quality etc.) to achieve CQV objectives.
  • Investigate deviations and write deviation reports and findings.
About this role

This is an exciting opportunity to join our organization and take on the challenge of ensuring the highest level of quality and compliance in our operations.

You will be working closely with our cross-functional teams to develop and implement effective validation strategies that meet regulatory requirements.

This is a critical role that requires strong technical skills, attention to detail and excellent communication skills.

Requirements

To be successful in this role, you will need:

  • Strong understanding of validation principles and regulatory requirements.
  • Excellent technical skills, including proficiency in software tools and systems.
  • Ability to work independently and as part of a team.
  • Excellent communication and interpersonal skills.
  • Proven track record of delivering high-quality results in a timely manner.
Benefits

We offer a competitive salary and benefits package, including:

  • Opportunities for career growth and development.
  • A collaborative and dynamic work environment.
  • A comprehensive training program to support your professional growth.
About us

We are a leading organization in the contract research development and manufacturing sector, dedicated to enabling scientists to translate their bench work into commercially available products at affordable prices.

We pride ourselves on our commitment to quality, innovation and customer satisfaction, and we are looking for talented individuals who share our values to join our team.

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