Company:  Confidential

Job Title: Validation Engineer

Job Number: 34748

Location: Petersburg, VA

Job Description

The validation engineer will oversee the CQV for a newly announced expansion of facilities for biologics. Collaborating closely with system owners and various stakeholders such as operations, engineering, laboratories, IT, and quality assurance, this position will steer CQV activities towards compliance at every stage of their development. Responsibilities encompass drafting, reviewing, and executing pertinent CQV documentation, as well as other documents relevant to the role such as procedures and change control records. Additionally, the role involves acting as an expert in CQV activities.

Responsibilities

● Contribute your validation expertise to the establishment of our facility.
● Be willing to engage in hands-on tasks within our team-oriented, fast-paced environment. The incumbent will offer technical guidance on CQV and ensure adherence to relevant standards.
● Be accountable for all CQV activities, covering various phases: from requirements and validation planning to protocol creation, test execution, configuration documentation, and system release.
● Timely execution of validation tasks is essential, with meticulous planning and proactive attention to details aimed at avoiding project delays.
● Strong interpersonal skills are crucial for managing interactions and achieving objectives across different functions within the site. Additionally, there may be a need for external communication with system vendors.

Required Skills

● Bachelor’s degree in engineering or a related scientific field with at least 7 years of experience in CQV.
● Minimum of 5 years’ experience specifically in sterile injectables, combination devices, or biologics.
● Previous experience in startup environments is desirable.
● Advanced degrees or certifications relevant to the role are advantageous.

 

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