Katalyst CRO ยท 3 months ago
Manufacturing Process Validation Engineer
El Paso, TX
Contract
Onsite
Senior Level, Lead/Staff
10+ years expKatalyst CRO is seeking a Manufacturing Process Validation Engineer for their state-of-the-art facility in El Paso, Texas. This role involves leading manufacturing process validation support activities and technical responsibilities for planning, executing, and coordinating validation processes.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling
Coordinates purchase and delivery of Equipment/Tooling
Coordinates installation of Equipment/Tooling
Develops and Executes IQ and OQ Protocols and Reports
Develops and Executes Test Method Validations / Gage R&R
Generates and Issues for Approval of SOPs and Manufacturing Procedures
Develops and Executes Component Qualifications
Develops and Executes PQ and PPQ Protocols and Reports
Develops Manufacturing Capacity Analysis
Develops and Executes Process Characterizations / Design of Experiments (DOE)
Develops documentation/justification for assigned capital projects
Complies with cGMP's, Quality Standards, and established policies and procedures
Executes other duties assigned by his supervisor
Qualification
Required
Bachelor's degree in engineering
Experience in the Medical Device Industries with experience in the Manufacturing Process Validation
Demonstrates excellent written and verbal communication skills (English and Spanish) across all levels
Qualification / Validation (IQ/OQ/PQ)
Test Method Validation / Gage R&R
Process Characterization / Design of Experiments (DOE)
Manufacturing Line Design / Capacity Analysis
Equipment / Tooling Design
Equipment Installation / Preventive Maintenance Procedure Generation
Root Cause Analysis / Investigation
Key word to search medical devices manufacturing process validation, 21CFR Part 820, ISO 13485, process validation, mold validation, SAP, process improvements
Good Manufacturing Practices (GMP)
Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks
Written and verbal communication skills (English and Spanish) and CFT interaction Expert 21CFR Part 820, ISO 13485 Good Process validation (IQ, OQ, PQ)
Mold validation, SAP, process Improvements
Good Manufacturing Practices (GMP)
Expert Medical Devices Manufacturing Processes changes and improvement Expert
SOP / Manufacturing Procedures Generation & Change Control
Product Financials & Supply Chain Structure Design
OEE Integration, Vertical Start up and Zero-loss mindset Required Education and
Requires a MS or bachelor's degree in engineering or related field with 10+ years of experience in an engineering role
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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