Katalyst CRO
Join to apply for the
CSV Engineer
role at
Katalyst CRO
6 days ago Be among the first 25 applicants
Roles & Responsibilities
Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries.
Direct experience with GxP equipment, IT systems, or manufacturing automation systems.
FDA and cGMP regulations and documentation practices.
GAMP 5 guidance.
21 CFR Part 11 and Annex 11.
Computer system validation methodologies.
Familiarity with risk-based validation execution strategies.
Strong technical writing skills with attention to detail.
Preferred Skills
Experience authoring SOPs for laboratory or manufacturing equipment.
Familiarity with LIMS, MES, SCADA, or laboratory instrumentation.
Prior exposure to audits or regulatory inspections.
Ability to manage multiple projects under tight deadlines.
Referrals increase your chances of interviewing at Katalyst CRO by 2x
Irvine, CA $141,000.00-$202,000.00
Seniority level Mid-Senior level
Employment type Contract
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr
CSV Engineer
role at
Katalyst CRO
6 days ago Be among the first 25 applicants
Roles & Responsibilities
Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries.
Direct experience with GxP equipment, IT systems, or manufacturing automation systems.
FDA and cGMP regulations and documentation practices.
GAMP 5 guidance.
21 CFR Part 11 and Annex 11.
Computer system validation methodologies.
Familiarity with risk-based validation execution strategies.
Strong technical writing skills with attention to detail.
Preferred Skills
Experience authoring SOPs for laboratory or manufacturing equipment.
Familiarity with LIMS, MES, SCADA, or laboratory instrumentation.
Prior exposure to audits or regulatory inspections.
Ability to manage multiple projects under tight deadlines.
Referrals increase your chances of interviewing at Katalyst CRO by 2x
Irvine, CA $141,000.00-$202,000.00
Seniority level Mid-Senior level
Employment type Contract
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr