Project Validation Engineer
Proclinical is currently recruiting for a Project Validation Engineer with a pharmaceutical company located in Santa Ana, CA.
- Participates in the local cross-functional operational governance process that prioritizes projects across quality, delivery, and cost, assigns cross-functional resources for execution, and provides updates on assigned projects against commitments. Capable of leading in the absence of technical management is necessary.
- Can lead and/or participates in at least three technical projects in parallel from the large and complex to smaller activities and tasks, utilizing appropriate Project Management / FPx tools and Six Sigma / Process Excellence tools. Delivers, through cross-functional coordination, not only the direct technical project activities but also all related regulatory, clinical, marketing, and other actions required to bring the project to market (e.g. a strong end-to-end mindset).
- Leads and/or participates in complex quality and failure investigations involving their project, partnering with the appropriate cross-functional resources and subject matter expertise as required, to identify root cause and implement corrective action. Communicates updates and progress and escalates appropriately.
- Provides guidance and input to leadership as it relates to the ability to maintain adequate support to meet delivery. Anticipates future constraints and raises, gains approval, and executes activities in advance of any constraints to ensure continuity of supply to customers.
- Employs their detailed knowledge of injection molding process parameters, toll / part design, assembly processes and techniques, LEAN/Six Sigma tools, and other engineering techniques to constantly identify, raise, gain approval, and execute, in collaboration with external and internal partners, to deliver improvement opportunities within the raw material supply chain against targets.
- Leads and/or participates in design changes to existing components and sub-assemblies, in partnership with appropriate design resources supporting lifecycle activities. Partners with R&D to delivery pFMEA's/control plans, ensuring the receipt of a stable and capable process into sustaining engineering on-going lifecycle technical support.
- As necessary, capable of managing all aspects of limited number of direct report resources and contractors assigned to the technical team, providing mentorship, guidance, and accountability.
- Maintains relationships with other Supplier Engineers and scientist as well as other functions to engage subject matter expertise on assigned projects as required. Represents a strong technical voice to the supplier and within the local environment in support of the Project.
- Ensures the Project Lead is appraised of all aspects of assigned projects and other activities as risk, issues, urgency, and progress dictate.
Skills and Requirements:
- A minimum of a BS degree (or equivalent) in a technical discipline. An advanced degree is preferred. A professional engineering certification is preferred.
- 10+ years of relevant experience (15+ years is preferred).
- Demonstrated technical project management skills and experience (PMP/PMI certification, FPx certification, or equivalent preferred).
- Demonstrated Six Sigma / Process Excellence / LEAN skills and related tool usage (Belt Certification preferred).
If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.