Validation Engineer

Katalyst Healthcares & Life Sciences

Houston, TX

Apply

JOB DETAILS

SKILLS

Biomedicine, Biotech and Pharmaceutical, Change Control, Chemical Engineering, Code of Federal Regulations, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Data Analysis, External Audit, FDA Requirements, ICH Regulations, Internal Audit, Manufacturing, Process Validation, Quality Assurance, Reporting Skills, Research & Development (R&D), System Validation, Temperature Mapping, Validation Plan

LOCATION

Houston, TX

POSTED

12 days ago

Summary :
We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team.

Roles & Responsibilities:

Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities.
Perform CQV activities, including Temperature Mapping for Controlled Temperature Units (CTUs).
Collaborate with Manufacturing, QA, Engineering, and R&D teams.
Analyze validation data, investigate deviations, and support CAPA implementation.
Prepare validation reports and support internal/external audits.
Review and support change controls for validated systems.

Education &Experience :

Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline).
2 6 years of validation experience in the pharmaceutical or biopharmaceutical industry.
Strong knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211 & 820), and ICH guidelines.
Hands-on experience with IQ/OQ/PQ and Temperature Mapping of Controlled Temperature Units is required.

Validation Engineer

Katalyst Healthcares & Life Sciences

Houston, TX

About the Company

Katalyst Healthcares & Life Sciences

Similar Job Searches