Job Number: 21-06389
Job Number: 21-06389
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Validation Engineer for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Maintains all qualified equipment systems in compliance with policies, guidelines and procedures:
- Develops qualification protocols, and associated reports while adhering to a change management process.
- Supports the execution of equipment qualifications and validation protocols.
- Supervises vendors for qualification functions.
- Develops written procedures for calibration and preventive maintenance of equipment.
- Supports calibration, equipment qualification and validation activities.
- Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
- Manages projects of limited scope and complexity within their functional area:
- Supports laboratory equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
- Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to Client standards.
- Provides excellent customer service and support:
- Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
- Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
- Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
- Familiarity with 21 CFR Part 11 compliance
- Knowledge of pharmaceutical laboratory and manufacturing systems. Preferred experience with Kaye validators, BSCs, refrigerators, welders, etc.
- Experience executing equipment qualification documents
- B.S. degree in Engineering or equivalent;
- Minimum 5 years of experience in FDA regulated industry, with 3 years of experience in equipment qualification.
- Ability to interact effectively with laboratory, QA, and Facilities groups
- Strong 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
- Strong written and verbal communication skills along solid presentation skills.
- Proficient at writing well-formulated emails and reports.
- Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
- Ability to effectively communicate with employees, contractors and vendors.
- Experience with technical writing and document development / generation
- Strong computer skills in Microsoft Office Suite Word, Excel and Outlook, and the ability to learn new software as required for equipment qualification.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Jay Lucas | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.