Katalyst CRO ยท 2 months ago
Process Development Engineer
Irvine, CA
Contract
Onsite
Mid LevelKatalyst Healthcares & Life Sciences is seeking a Process Development Engineer to oversee the planning, coordination, and execution of project deliverables in compliance with regulations. The role involves performing characterization studies, writing process instructions, and collaborating with cross-functional teams to ensure successful manufacturing operations.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Must be able to perform characterization studies with statistical analysis and create test reports Process Development and Validation Experience is a must
Must write process instructions, manufacturing operating procedures, and PFMEAs Must build equipment and setup manufacturing line(s)
Process and run engineering Wos
Able to travel within USA and Mexico if required to write and execute IQOQPQ
Must be able to write and stage CRs CNs in Windchill Responsible for the successful planning, coordination, execution, implementation, and timely completion of project deliverables ensuring consistency with company policies, procedures, and commitments Lead and drive execution of design for manufacturing including component manufacturing within the principles of DMAIC Develop innovative workflows to generate compelling technical evidence of product or project performance under challenging conditions Prepare and present technical information in a clear and effective manner to project leads, managers, stakeholders Review and coordinate drawings, BOMs, specifications, protocols, test reports, plans, etc
Actively coordinate and mitigate delays within project and tasks Collaborate with cross-functional team, work with engineering, manufacturing, marketing and suppliers
Qualification
Required
Must be able to perform characterization studies with statistical analysis and create test reports
Process Development and Validation Experience is a must
Must write process instructions, manufacturing operating procedures, and PFMEAs
Must build equipment and setup manufacturing line(s)
Process and run engineering Wos
Able to travel within USA and Mexico if required to write and execute IQOQPQ
Must be able to write and stage CRs CNs in Windchill
Responsible for the successful planning, coordination, execution, implementation, and timely completion of project deliverables ensuring consistency with company policies, procedures, and commitments
Lead and drive execution of design for manufacturing including component manufacturing within the principles of DMAIC
Develop innovative workflows to generate compelling technical evidence of product or project performance under challenging conditions
Prepare and present technical information in a clear and effective manner to project leads, managers, stakeholders
Review and coordinate drawings, BOMs, specifications, protocols, test reports, plans, etc
Actively coordinate and mitigate delays within project and tasks
Collaborate with cross-functional team, work with engineering, manufacturing, marketing and suppliers
EIS : Medical Device & Regulations
EIS : New Product Development (NPD) Methodology and Management
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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