Apply to Validation Engineer, Biopharma, Hybrid (once/week onsite) - (JP10478)

Job Title: Validation Engineer, Biopharma, Hybrid (once/week onsite) - (JP10478)
Location: Thousand Oaks, CA (Hybrid, once a week on site)
Employment Type: Contract
Business Unit: AutoTouch Platform Team
Duration: 1+ years with likely extensions
Posting Date: 06/24/2022

3 Key Consulting is hiring a Validation Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Scope includes electro-mechanical delivery devices, such as fluid transfer devices, reusable automatic injectors, or micro-infuser delivery pump systems with the embedded firmware and hardware. The qualified candidate will be part of a sustaining device engineering team that ensures the design history files of these systems are maintained. The engineer will participate in multi-functional teams, device verification activities such as revising product requirement specifications, supporting new development project teams, analytical failure analysis and implementing design solutions, authoring verification protocols and compiling verification report and getting them ready for approval.

Responsibilities:

Accountable for maintaining technical records within design history files associated with assigned products.
Support system-level design, development, and V&V work for commercial lifecycle management changes or in support of new project development.
Develop test methods, generate, and maintain design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
Participate system-level and subsystem-level root cause investigation from firmware and electrical perspective, coordinate design improvements with development partners, tactical planning, and execution of design changes and improvements.\
Supports Product Delivery Teams (PDT), including creating and or reviewing quality documents, participating in Corrective And Preventive Action (CAPA) implementation, and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order) activities.
Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.

Basic Qualifications:
Doctorate Degree, or Master’s Degree and 2 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment, or Bachelor’s Degree and 4 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment.

Preferred Qualifications:

Master’s degree in biomedical/electrical/computer science or related Engineering field and 4+ years of related engineering experience
A background in the development and commercialization of class II or class III electromechanical medical devices especially drug delivery devices, syringe and vial fill process
Systems Engineering design experience and thinking, driving user needs to design requirements to verified and validated final product outputs through design requirement management system such as DOORs, RequisitePro, Quality Center or equivalent.
Strong understanding and experience in design controls, life cycle management through design change control process, failure investigation and root cause analysis, initiating and bringing complex projects to conclusion
Familiar with the following standards and regulations: Quality System Regulation – 21CFR820, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive 93/42/EEC, Drug delivery device and needle standard - ISO 11608-1/ISO 11608-4/ISO 11608-5/ISO_23908, and biocompatibility standard - ISO 10993
Familiar with electrical schematic design and layout, and embedded software coding structure and workflow
Understanding of Medical Device software and hardware design requirements.
Understanding of ISO 62304 and FDA software validation requirements
Ability to work independently and across functional teams.
Excellent (technical) written and verbal communication

Top Must-Have Skill Sets:

Software, hardware, or any engineering background
Willing to look at new grads- ideal candidate 2+ years
BS degree in engineering, brioche, biomedical, chemistry
Knowledge or experience of IEC60601, ISO13485, ISO 14791 or FDA Title 21 CFR 820 (preferred)

Red Flags:
No BS degree
No engineering or science background, nonrelated experience

Interview process:
Phone screen, then panel video interview.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.