Want to know if you’re a fit?
Upload your resume and let our AI show you.
Upload your resume and let our AI show you.
Skills
- Analysis Skillsunmatched
- Biotech and Pharmaceuticalunmatched
- Calibrationunmatched
- Change Managementunmatched
- Code of Federal Regulationsunmatched
- Commissioningunmatched
- Commissioning - Engineeringunmatched
- Communication Skillsunmatched
- Computer Skillsunmatched
- Computer Systemsunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Customer Relationsunmatched
- Customer Support/Serviceunmatched
- Data Managementunmatched
- Database Technologyunmatched
- Dental Insuranceunmatched
- Detail Orientedunmatched
- Diversityunmatched
- Documentationunmatched
- Drug Manufacturingunmatched
- Environmental Monitoringunmatched
- Equipment Maintenance/Repairunmatched
- Equipment Validationunmatched
- Establish Prioritiesunmatched
- GMP (Good Manufacturing Practices)unmatched
- Geneticsunmatched
- GxPunmatched
- Healthcareunmatched
- Interpersonal Skillsunmatched
- Intranetunmatched
- Laboratory Systemsunmatched
- Maintain Complianceunmatched
- Manufacturing Systemsunmatched
- Medical Productsunmatched
- Microsoft Excelunmatched
- Microsoft Officeunmatched
- Microsoft Outlookunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Multitaskingunmatched
- Operations Planningunmatched
- Organizational Skillsunmatched
- Presentation/Verbal Skillsunmatched
- Preventative Maintenanceunmatched
- Problem Solving Skillsunmatched
- Procedure Developmentunmatched
- Project Scheduleunmatched
- Project/Program Managementunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Relationship Managementunmatched
- Requirements Managementunmatched
- Requirements Validation/Verificationunmatched
- Safety Complianceunmatched
- Software Development Lifecycle (SDLC)unmatched
- System Validationunmatched
- Team Playerunmatched
- Technical Supportunmatched
- Time Managementunmatched
- Traceabilityunmatched
- Validation Documentationunmatched
- Validation Planunmatched
- Vendor/Supplier Managementunmatched
- Vision Planunmatched
- Writing Skillsunmatched
Description
Equipment Commissioning & Qualification (ECQ) Engineer
Job Number: 26-01335
Job Number: 26-01335
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for an Equipment Commissioning & Qualification (ECQ) 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!
Position Overview:
- The Engineer, Equipment Commissioning & Qualification (ECQ) Delivery supports the successful implementation of equipment / instruments, facilities, and utilities, at multi-use sites through interaction with internal customers and external service providers.
- The person in this role is responsible for commissioning, qualifying and / or maintaining equipment / instruments, facilities, and utilities, in a commissioned / qualified / validated state according to established policies and procedures. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses basic analytical skills to recognize and solve common problems of limited scope.
- This role will require management of outside resources, and their own workload.
- As a developing team player, the person in this role interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
- Reporting Relationship Manager or Senior Manager
Responsibilities:
- Commissioning and Qualification Activities:
- Maintain commissioned / qualified equipment, facilities, and utilities in compliance with policies, guidelines, and procedures:
- Develop commissioning / qualification protocols, and associated reports while adhering to a change management process.
- Supervise vendors for qualification functions.
- Support development of equipment operational procedures.
- Support all equipment validation activities. Execute equipment qualifications and validation protocols.
- Develop validation / qualification deliverables such as Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports.
- Support Change Management process.
- Maintain commissioned / qualified equipment, facilities, and utilities in compliance with policies, guidelines, and procedures:
- Project Work Support:
- Manage projects of limited scope and complexity within their functional area:
- Support equipment implementation projects including scheduling, site prep, installation, qualification, and turnover to business area.
- Support internal customer groups in the operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
- Complete all qualification and validation documentation with accuracy, completeness, and compliance to Client standards.
- Manage projects of limited scope and complexity within their functional area:
- Customer Service and Support:
- Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests.
- Provide technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
- Provide technical support and guidance on equipment, utilities, facilities, and computerized systems qualification and validations issues.
- Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
- Regulatory Responsibilities:
- Ensure equipment, facilities and programs are maintained in compliance.
- May participate in deviation investigations as an SME.
Qualifications:
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Knowledge of pharmaceutical, manufacturing and laboratory systems.
- Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
- Strong written and verbal communication skills.
- Excellent interpersonal skills with experience dealing with a diverse workforce.
- Strong multitasking 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.
- Detail-oriented with strong commitment to quality, safety, and compliance.
- Ability to effectively manage multiple projects simultaneously and prioritize tasks effectively.
- 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 tools.
- Experience with Electronic Data Management Systems such as Valgenesis, preferred.
- BS in Engineering or Science related discipline preferred but can be substituted with sufficient relevant experience.
- Minimum of 5 years of experience performing / supporting activities in a GMP environment.
- Minimum of 3 years of experience in equipment, facilities, or utilities qualification.
Pay Rate: $61.95 - $65.70 / Hour
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
212-804-7476
June Binuya | LinkedIn
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.
Numbers & Facts
| Location | Summit, NJ |
| Industry | Staffing/Employment Agencies |
| Salary | $61.95–$65.70 Per Hour |
| Company Size | 500 to 999 employees |
| Year Founded | 1999 |
| Website | http://www.eclaroit.com |
About Company
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.
See ourPrivacy Noticefor information on pixel tracking.