Ecq Engineer Jobs (NOW HIRING)

Equipment Commissioning & Qualification (ECQ) Engineer- Pharma (Onsite – Summit, NJ) 

We are seeking an Equipment Commissioning & Qualification (ECQ) Engineer for our global pharmaceutical client. 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 is a 40-hour per-week, 6-month contract (extensions possible), 100% onsite at the client’s office in Summit, NJ. 

This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered. 

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. 

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 turn over 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’s standards. 

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. 

• Reporting Relationship Manager or Senior Manager 

Requirements: 

• 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. 

• 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. 

• Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. 

• 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. 

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Equipment Commissioning & Qualification (ECQ) Engineer- Pharma (Onsite – Summit, NJ) role). 

Please feel free to forward this project opening to others who may be interested. 

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics. 

Compensation: $58/hr. - $60.65/hr on W2. 

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