What are the responsibilities and job description for the Calibration Engineer position at Eliquent Life Sciences, Inc?
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.
The Equipment Engineer hired for this role will execute equipment calibration, preventative maintenance, performance verification and repair activities in both laboratory and manufacturing areas.
Responsibilities:
- Supervises vendors for calibration, preventative maintenance, performance verification and repair functions.
- Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, completeness and compliance to company standards.
- Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
- Writes and supports deviations that result from calibration or performance verification failures along with developing and supporting the implementation of corrective and preventative actions.
- Support the development, revision and review of written procedures for calibration, preventive maintenance and performance verification of equipment.
- Support the development, review and approval of calibration and maintenance plans including asset induction requests/modifications
- Supports the execution of equipment performance verification and process improvement studies.
- Regularly reviews, prioritizes and promptly responds to customer equipment performance verification and support requests.
- Provides technical support and guidance on calibration, equipment performance verification and validations issues. Interfaces with customers to ensure all expectations are being met.
Requirements:
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
- Strong written and verbal communication skills.
- Excellent interpersonal skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
- Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
- Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
- Working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM.
- Ability to interact effectively with laboratory, QA and Facilities groups.
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.
Salary : $45 - $60