Job Title: Validation Engineer

For immediate consideration, please apply directly to this job posting AND email me at scortez @actalentservices.com with the following:

1) Word copy of resume

2) 2-3 professional references

3) 4-5 brief bullet points highlighting technical qualifications

***THIS IS NOT A SOFTWARE POSITION*** Looking for hands on IQ/OQ/PQ Validation in Medical Device Candidates!!!

MUST HAVE

• Bachelor of Science in Engineering or a related subject with 4+ years of experience in validation GMPs.
• Good understanding of engineering and machine tool fundamentals.
• Written and owned the validation process
• SME on IQ/OQ/PQ
• FDA Audit experience and ability to be apart of the Audit
• Knowledge/experience of Risk Based Techniques, such as FMECAs, FTAs, RMF.
• Understanding of statistical techniques, particularly statistical sampling plans, process capability, and R&Rs.
• Highly developed problem-solving and strong analytical skills.
• Excellent knowledge of all validation elements and attention to detail.
• Good influencing and communication skills with a practical and compliant approach.
• Lean Six Sigma training is a distinct advantage.

Job Description

As a member of the Global GQO-QA Validation team, the Staff Validation Engineer will support validation projects and initiatives according to business needs. This role involves coaching and guiding multifunctional engineering teams to effectively establish and meet validation and process development corporate requirements. You will be responsible for local validation teams in terms of technical expertise and definition of best practices. This position holds high visibility and involves high-risk decision-making. As an individual contributor, you will use your judgment in applying professional expertise and are expected to work independently with minimal supervision.

Responsibilities

• Provide interpretation and guidance on regulations, corporate, divisional, and site local procedures related to validation activities.
• Participate in the Corporate Validation Team to develop and revise validation procedures and templates, ensuring compliance with current regulatory standards and company objectives.
• Participate in corporate and local validation teams to discuss, provide feedback, and approve revisions to validation procedures.
• Represent validation at both internal and external audits.
• Work as part of several cross-functional local and global teams; visit and work on manufacturing sites as required, on a hybrid basis.
• Guide the definition of validation strategies for highly complex validation projects across multiple sites.
• Ensure that validation practitioners receive training and coaching to effectively support and perform validations for current and anticipated projects.
• Ensure appropriate systems are in place to evaluate changes to validated/qualified systems, maintaining their validated/qualified state.
• Utilize quality engineering tools, statistical methods, design development methods, process development/control methods, and process verification/validation planning to incorporate quality into new and existing products.
• Implement and develop the validation process for newly acquired sites as part of mergers and acquisitions teams.
• Work closely with product transfer, NPI, NPD, and AO teams.
• Lead validation continuous improvement projects.
• Implement lean and Six Sigma initiatives and lead teams to apply these methodologies.
• Act as the Subject Matter Expert responsible for at least two validation specialties and provide primary support for those specialties, such as Computer System Validation (CSV) or Qualification of Buildings, Facilities and Utilities (BFU).

Work Environment

The position is onsite in Irvine, CA. Employees can expect a professional environment that fosters collaboration and innovation.