Senior CQV Engineer

Job Title : Senior CQV Engineer

Location : Greenville, NC

Experience : 5+ years

Duration : 12+ months

Job Responsibilities

Draft and maintain protocol templates, media fill summaries, and standardized reports.

Populate bracketing documentation tables and support protocol generation.

Manage central trackers for protocol reviews, approvals, and interventions.

Coordinate feedback cycles with site and global stakeholders; update documentation accordingly.

Provide execution support to ensure project milestones and deliverables remain on schedule.

Collaborate cross-functionally with Validation and QA leads to support documentation and onsite activities.

Requirements

Bachelor's Degree in a relevant scientific or engineering discipline.

Minimum 5+ years of industry experience, including hands-on experience with Media Fill Validation .

Proven expertise in Commissioning & Qualification (C&Q) and Validation activities.

Strong background in authoring and executing protocols, as well as drafting media fill summaries and reports.

Experience working in a pharmaceutical / FDA-regulated manufacturing environment .

Solid understanding of cGMP requirements, facility / equipment validation, and regulatory expectations.

Excellent technical writing skills with the ability to communicate clearly and persuasively.

Strong interpersonal skills with demonstrated ability to interact effectively across all levels of the organization.

Ability to work collaboratively within cross-functional teams.

High attention to detail, problem-solving ability, and critical thinking skills.