Job Number: 24550481
EQUIPMENT VALIDATION ENGINEER
100% Onsite Required .
Must have: Experience Developing Validation/Qualification Deliverables: Validation Plans, Requirement Specifications, Traceability Matrices, Summary Reports, Change Controls .
Pay ranges between $74.35 - $79.27/hr W2.
- BS in Engineering or Science related discipline required .
- 5 years' experience performing/supporting activities in a GMP environment.
- 3 years' experience in Equipment, Facility or Utility Qualification.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Experience in the qualification of cell therapy equipment a plus .
- Advanced 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 multi tasking 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.
- Ability to effectively manage multiple tasks and activities simultaneously.
- 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.
WORKING CONDITIONS (US Only):
- The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers.
- The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures.
- The individual participates in projects and ongoing work activities of low to moderate complexity.
- 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
- Maintains 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 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 equipment implementation projects including scheduling, procurement, site prep, installation, qualification, 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 qualification and validation documentation with accuracy, completeness, and compliance with 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 qualification issues. Interfaces with customers to ensure all expectations are being met.
- Provides technical support and guidance on equipment and computer systems qualification and validations issues.
- Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
- Ensure equipment, facilities and programs are maintained in compliance.
- May be called upon as SME in both internal and regulatory audits.
- Physical / Mental Demands:
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs .
- Ability to sit, stand, walk, and move within workspace for extended periods .
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.
- Environmental Conditions:
- Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
- Ability to work safely and effectively when working alone or working with others.
This 6+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Loren: loren@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-01288
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE