Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation support - TechDigital Corporation
Warren, NJ 07059
About the Job
Equipment Delivery Engineer
This role is 100% Onsite---Local Candidates Only Please
Work Schedule: Mon - Fri, Business Hours
1. PURPOSE AND SCOPE OF POSITION:
The Equipment Delivery Engineer supports the successful implementation of laboratory equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role contributes to the completion of milestones associated with laboratory equipment installation and release for use. 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. As a developing team player, the incumbent 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.
2. REQUIRED COMPETENCIES
Knowledge, Skills & Abilities:
• Understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry
• Knowledge of pharmaceutical laboratory and manufacturing systems. Experience with common equipment, such as (BSCs, refrigerators, freezers, centrifuges, balances, etc.) is required. Experience with cell therapy equipment and lab instruments (bioreactors, cell separators, plate readers, flow cytometers is preferred.
• Ability to interact effectively with Laboratory, IT, Engineering, and Facilities groups.
• Strong ability to organize assigned tasks in a fast-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. Proficiency in writing well- formulated emails and reports. Ability to follow oral and written instructions.
• Experience with scheduling equipment vendors and service providers. Experience with electronic asset management systems (e.g.,BMRAM, Maximo) is preferred.
• Strong ability to read and interpret engineering drawings and equipment manuals relevant to the assigned task.
Experience with technical writing and document development / generation is preferred.
• Ability to effectively communicate with employees, contractors, and vendors.
• Strong computer skills in Microsoft Office Suite – Word, Excel and Outlook, and the ability to learn new software
as applicable to installation and release of equipment.
3. DUTIES AND RESPONSIBILITIES
Delivers laboratory equipment and systems in compliance with policies, guidelines and procedures:
• Maintains awareness of the business equipment requirements via interaction with Business Owners, Project
Engineering, and Lab Operations
• Supervises vendors for equipment installation and documentation completion.
• Maintains equipment documentation, updates electronic equipment inventory system.
Manages projects of limited scope and complexity within their functional area:
• Executes laboratory equipment implementation projects including scheduling, procurement, site prep,
installation, and turnover 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 required documentation with accuracy and compliance to company 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 equipment installation and site readiness 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.
4. EDUCATION AND EXPERIENCE
• B.S. degree in Engineering or equivalent required
• Minimum 5 years of experience in FDA-regulated industry such as pharma, biotech, or medical devices. Cell
therapy experience is strongly preferred.
This role is 100% Onsite---Local Candidates Only Please
Work Schedule: Mon - Fri, Business Hours
1. PURPOSE AND SCOPE OF POSITION:
The Equipment Delivery Engineer supports the successful implementation of laboratory equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role contributes to the completion of milestones associated with laboratory equipment installation and release for use. 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. As a developing team player, the incumbent 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.
2. REQUIRED COMPETENCIES
Knowledge, Skills & Abilities:
• Understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry
• Knowledge of pharmaceutical laboratory and manufacturing systems. Experience with common equipment, such as (BSCs, refrigerators, freezers, centrifuges, balances, etc.) is required. Experience with cell therapy equipment and lab instruments (bioreactors, cell separators, plate readers, flow cytometers is preferred.
• Ability to interact effectively with Laboratory, IT, Engineering, and Facilities groups.
• Strong ability to organize assigned tasks in a fast-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. Proficiency in writing well- formulated emails and reports. Ability to follow oral and written instructions.
• Experience with scheduling equipment vendors and service providers. Experience with electronic asset management systems (e.g.,BMRAM, Maximo) is preferred.
• Strong ability to read and interpret engineering drawings and equipment manuals relevant to the assigned task.
Experience with technical writing and document development / generation is preferred.
• Ability to effectively communicate with employees, contractors, and vendors.
• Strong computer skills in Microsoft Office Suite – Word, Excel and Outlook, and the ability to learn new software
as applicable to installation and release of equipment.
3. DUTIES AND RESPONSIBILITIES
Delivers laboratory equipment and systems in compliance with policies, guidelines and procedures:
• Maintains awareness of the business equipment requirements via interaction with Business Owners, Project
Engineering, and Lab Operations
• Supervises vendors for equipment installation and documentation completion.
• Maintains equipment documentation, updates electronic equipment inventory system.
Manages projects of limited scope and complexity within their functional area:
• Executes laboratory equipment implementation projects including scheduling, procurement, site prep,
installation, and turnover 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 required documentation with accuracy and compliance to company 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 equipment installation and site readiness 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.
4. EDUCATION AND EXPERIENCE
• B.S. degree in Engineering or equivalent required
• Minimum 5 years of experience in FDA-regulated industry such as pharma, biotech, or medical devices. Cell
therapy experience is strongly preferred.
Source : TechDigital Corporation
