Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences,…
Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences,…
This position is open exclusively to people who are eligible to work in USA
Position Summary
We are seeking a skilled
CQV Engineer
to support commissioning, qualification, and validation activities for equipment, utilities, and processes in a regulated
pharmaceutical/biotech environment
. The ideal candidate will have hands-on experience in executing CQV lifecycle activities and ensuring compliance with regulatory standards such as FDA and GMP.
Key Responsibilities
Required Qualifications
Bachelor’s degree in
Engineering
(Mechanical, Chemical, Biomedical, or related field)
5+ years
of experience in CQV/Validation in pharma, biotech, or medical device industry
Strong experience with
IQ/OQ/PQ execution
Knowledge of
GMP, FDA 21 CFR Part 11/820, and GAMP 5
Experience with utilities (HVAC, Water Systems, Clean Steam) and process equipment
Preferred Qualifications
Experience with
cleanroom validation and environmental monitoring
Exposure to
automation/CSV systems (SCADA, PLC, MES)
Familiarity with
risk management tools (FMEA, HACCP)
Experience in
greenfield or brownfield projects
Knowledge of
statistical tools and process validation lifecycle
Execute
Commissioning, Qualification, and Validation (CQV)
activities for equipment, utilities, and facilities
Develop and execute validation protocols including
IQ, OQ, PQ
Perform
risk assessments (FMEA)
and impact assessments for systems and processes
Review and approve engineering and validation documentation (URS, FS, DS, SOPs)
Support
FAT/SAT, commissioning, and startup activities
Ensure compliance with
cGMP, FDA regulations (21 CFR), and GAMP guidelines
Investigate deviations, CAPAs, and non-conformances related to validation activities
Collaborate with cross-functional teams (Engineering, QA, Manufacturing, Automation)
Support audits and regulatory inspections
Maintain proper documentation and validation lifecycle traceability
Strong documentation and technical writing skills
Ability to work independently in a fast-paced environment
