Associate Validation Engineer

Job Description

Job Description

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com..

• Support the facility and utility engineering function including the design, commissioning and operation of relevant unit operations (boilers, compressors, high purity water treatment, HVAC, etc), including project updates and maintaining utility and facility equipment project life cycle documents (reliability, maintenance, operations standard operating procedures).
• Develop conceptual engineering designs improvements and the corresponding process flow diagrams and piping/instrumentation diagrams.
• Develop design documents for the utility and facility equipment in accordance with Good Engineering Practice, (GMP)
• Develop utility and facility equipment procurement specifications and data sheets based on approved design documents.
• Support the development of equipment and facility bid evaluations for procurement of the utility and facility equipment and system construction packages.
• Review vendor equipment drawings and specifications and drive the system integration with the site utilities and computerized systems (SCADA).
• Participate in multi-functional design reviews, identify gaps to the original design documents and update design documents as required to remediate gaps.
• Prepare change control documents and justifications as required.
• Develop commissioning and qualification documents for facility and utility equipment and the associated manufacturing lines.
  

Requirements

Qualifications

• Education: BS/BA degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering is a plus.
• 1-2 year experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
• Excellent written and verbal communication skills; excellent technical writing skills. ∙ Strong interpersonal skills and the ability to work in a team environment.
• Ability to work effectively in a fast-paced multitasking environment.
• Proficient in Microsoft Word, Excel, PowerPoint.
• Working for multiple clients throughout the region.

Benefits

What We Offer:

• Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.