Senior Validation Engineer

1 week ago


Norwood, Massachusetts, United States Randstad Life Sciences US Full time
Job Summary

We are seeking a highly skilled Senior Validation Engineer to join our team at Randstad Life Sciences US. As a key member of our Commissioning, Qualification, and Validation (CQV) team, you will be responsible for delivering commissioning, qualification, and validation activities to ensure equipment and systems remain in a qualified operational state of compliance within a GCLP/GLP Laboratory environment.

Key Responsibilities
  • Commissioning, Qualification, and Validation Activities: Execute commissioning, qualification, and validation activities to maintain compliance with GCLP guidelines and GLP regulations.
  • Documentation and Record-Keeping: Author and execute design, commissioning, qualification, and validation documentation and support records to certify compliance with specifications and procedures.
  • Quality System Management: Ensure timely resolution of documentation compliance and quality system issues.
  • Deviation Investigation: Investigate deviations related to qualification and validation activities.
  • Collaboration and Communication: Participate in cross-functional teams to meet project timelines and business needs while adhering to regulatory requirements.
  • Standard Operating Procedures: Ensure Standard Operating Procedures (SOPs) and procedures are created, understood, and followed.
  • Training and Development: Participate in XXX training to support CQV requirements.
Requirements
  • Education: B.S. in engineering, science, or an equivalent technical field.
  • Experience: Minimum of one (1) year of relevant experience in a GCLP/GLP environment is desirable.
  • Skills and Abilities: Understanding of commissioning, qualification, and validation principles. Strong technical documentation generation and review skills, ensuring content is technically sound and adheres to applicable site procedures. Ability to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Excellent interpersonal and communication skills (verbal and written), with the ability to present work to peers and cross-functional managers and influence leadership decisions.

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