Validation Engineer

Validation Engineer
  • Competitive
  • Temporary
  • Fremont CA, US Fremont ALAMEDA US 94555
Job Ref: JO000126638
Sector: Clinical
Sub-sector: Quality
Date Added: 15 December 2021


Validation Engineer - Shipping and Cold Chain expertise


12 months contract

Ideal start date - 1/17/22

Location - Fremont, CA

Client is looking for onsite/local resources. Client will consider some of the work to done remotely and expenses covered when traveling to the site if ideal candidates are not local.

Open to regional candidates as well.

JOB DESCRIPTION - Client has a new partner with a new warehouse that needs to validated.

Must Have Shipping/Cold Chain Validation experience

Desired Experience, Skills and Abilities:
• Bachelor's Degree from an accredited institution in Life Sciences or Engineering, with six (6) years of pharmaceutical Quality experience, knowledge of Validation Lifecycle Approach, preferably validation experience in biopharmaceuticals.
• Master’s Degree from an accredited institution in Life Sciences or Engineering, with four (4) years of pharmaceutical quality experience, and two (2) years of Validation Lifecycle Approach, preferably validation experience in biopharmaceuticals.
• Experience leading people and/or projects with history of achieving results and outstanding outcomes. Developed leadership and mentoring experience desired.
• Excellent technical writing and verbal communication skills.
• Thorough knowledge of GMP Pharmaceutical manufacturing.
• Experience in reading and interpreting process development and characterization documents
• Experience in interpreting and relating Validation standards for implementation and review to functional areas.
• Advanced knowledge of relevant regulations and guidance required in order to act as a resource for colleagues.
• Proven project-management skills required. Must be able to manage multiple projects against given time-lines.
• Independent decision making capability and ability to think conceptually and understand impact of decisions critical to product quality.
• Must be able to independently represent the department in a wide-assortment of situations
• Possesses excellent verbal and written communication skills; good interpersonal skills.
• Experience in managing technical projects with an interdisciplinary project team, from planning to realization and start up.
• Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
• Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.
• Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.
• Expert in leading risk assessments, executes critical decision making, works independently with very little supervision, champions problem resolution, knows when to escalate to upper management, and provides compliant and smart solutions for complex validation issues.
• Expert understanding of validation principles in pharmaceutical / biopharmaceutical / medical device industries.
• Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place.
• Influences and leads inter-departmental meetings with cross functional managers to resolve issues and produce solutions.
• Manages deviation investigations as applicable and provides validation impact assessment. Ensures deviations assigned are promptly closed.
• Expert understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.
• Ability to facilitate conflict resolution and negotiation skills.
• Proven ability to establish good relationships with others who have different values, cultural styles and perspectives.
• Track record of setting high and ambitious goals and standards for oneself and others, continuously raises the bar.
• Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
• Must possess excellent verbal and written communication skills; good interpersonal skills.

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.


28/02/2022 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Philip Mills

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