What are the responsibilities and job description for the QC Instrument Lifecycle Validation Engineer position at Eclaro?
Job Number: 23-02611
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!
Responsibilities:
- Act as the project lead for qualification of QC equipment and its associated software
- Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, configuration specifications, risk assessments, qualification summary report
- Author/execute computer system validation scripts
- Own change controls specific to the qualification of QC instruments and its associated software
- Update the asset management database to reflect new assets, calibrations, preventative maintenances
- Author instrument operational SOPs as needed
- Coordinate/interface/host vendors on site
- Champions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/Client)
- Acts as the liaison between Digital Plant (IT) and lab departments
- Complete decommissioning/periodic assessments
Required Qualifications:
- Bachelors degree in relevant scientific, engineering, or computer-based area with 4 7 years experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.
- Quality management system experience including document control/management, change controls, investigations, deviations, electronic validation databases, asset management database
- Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery
- Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects
- Demonstrated success in cross functional influencing, strong communication, and collaboration skills
- Must have equipment validation experience
- Must have GMP experience
- Must have Quality Management System (QMS) experience
Experience:
- Working knowledge of laboratory systems such as Empower, NuGenesis and other software programs, including Microsoft Office Applications, preferred.
- Experience in Computer System Validation is a plus.
- Experience in any asset management software is a plus.
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:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | 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.
About the Company:
Eclaro
Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:
• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities
Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:
• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services
Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.
Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.
Company Size:
500 to 999 employees
Industry:
Staffing/Employment Agencies
Founded:
1999
Website:
http://www.eclaroit.com
