Lead CQV Engineer — Validation & Commissioning

FITS LLC; Northern (KY); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Excellent customer service

Job summary

FITS LLC in Kentucky is seeking Validation, Commissioning & Qualification support in the Engineering area. The role requires a Bachelor's in Life Science or Engineering and experience in Validation Life Cycle within the pharmaceutical industry, plus bilingual Spanish and English.

As a CQV specialist, you will develop CQ plans, lead cross-functional CQV/Eng/CM/USER meetings, manage deviations changes, and ensure documentation quality in line with cGMP and Data Integrity guidelines.

Qualifications

• Must have a Bachelor’s degree in Life Science or Engineering and experience in Validation Life Cycle in the pharmaceutical industry.
• Bilingual Spanish and English written and spoken.
• Administrative shift, flexible to business needs.
• Strong skills in writing documentation in English and using MS Office.
• Experience in Process Commissioning and Qualification and Validation coordination activities.
• Familiarity with Change Control development, cGMPs and Data Integrity.

Responsibilities

• Develop an overall CQ plan in collaboration with the Client project scheduler and meet key milestones.
• Lead weekly multidisciplinary CQV/Eng/CM/USER coordination meetings; manage organization and resources.
• HSE and Safe Start-Up activities including LOTO; CQV documentation preparation and execution readiness.
• Develop and review CQ test plans and specifications prior to approvals.
• Create and maintain training materials and files for CQV teams and stakeholders.
• Manage CQV documentation filing and ensure schedule compliance at system/area level.

Skills

Bachelor's Degree in Life Science or 4

Bilingual (Spanish & English)

MS Office (Excel, Word, PPT)

Validation Life Cycle experience

Process Commissioning andQualification

Validation coordination activities

Change Control Development

cGMP & Data Integrity knowledge

Education

Bachelor's Degree in Life Science or Engineering

Tools

MS Office

Job description

FITS LLC in Kentucky is seeking Validation, Commissioning & Qualification support in the Engineering area. The role requires a Bachelor's in Life Science or Engineering and experience in Validation Life Cycle within the pharmaceutical industry, plus bilingual Spanish and English.

As a CQV specialist, you will develop CQ plans, lead cross-functional CQV/Eng/CM/USER meetings, manage deviations changes, and ensure documentation quality in line with cGMP and Data Integrity guidelines.