Who we are:  

NEXA | EAM, a Transcat company, founded in 2015 in Ireland, began with just one client and one employee. Today, we are a trusted advisor to leading companies in the Life Sciences industry around the world with a growing team of over 100 employees. Our team of understanding, talented professionals create value for leading Life Sciences companies by focusing on the delivery of Asset Management solutions to enable world-class production. Our commitment to achieving excellence helps our clients accelerate the delivery of life-changing products to market. We achieve this through our people, who are always our highest priority. Are you ready to join a growing team that values your contributions, development, and wellness?  

Here’s what you’ll get: 

• Never a dull moment! - Exposure to diverse projects with collaborative teams.
• A work environment that is both rewarding and challenging.
• In-person and virtual social gatherings and events.

NEXA |EAM is searching for: 

Multiple roles including fully onsite, hybrid, and fully remote Computer Systems Validation (CSV) consultants. CSV consultants will support our clients with activities related to the set up or optimization of their Computer Systems Validation/ Data Integrity program at multiple locations in the Boston, MA area. You will work on one of our new, leading Life-Science client sites and will report directly to our NEXA, CQV Director.. 

In this project, you will: 

• Perform validation for new and modified DeltaV installations, as well as qualifying the associated manufacturing equipment connected to DeltaV.

• Develop computer systems validation plans, user requirement specifications, functional specifications, configuration specifications, hardware design specifications, qualification test protocols (IQ/OQ/PQ), traceability matrices, validation reports, and other deliverables within the scope of the Software Development Lifecycle (SDLC). Experience with all of these deliverables is not required; validation protocol writing and execution experience is required, at minimum.

• Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology.

• Assist with the development of system requirements and specifications to ensure requirements are testable, and 21 CFR Part 11 requirements are met.

• Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans for computer systems.

• Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies, and change control documents.

• Evaluate proposed changes to validated computer systems and recommend level of validation activities required.

• Assist with other projects, as required.

We are looking for people with: 

• Previous validation experience with Distributed Control Systems (DCSs) is highly desired; validation experience with DeltaV is highly desired.

• Bachelor’s degree in Engineering, Science, or Computer Science. Associates, bachelor’s degree, or trade certification in a related Engineering field.

• In the absence of the above, 3 years of CSV experience in an FDA regulated industry.

• Excellent interpersonal, communication, organizational, and project management skills.

• Experience in the review, evaluation and testing of systems to ensure compliance with the FDA Electronic Records/Electronic Signatures regulation.

• Ability to multi-task in a high volume, fast-paced work environment with strict deadlines.

• Strong computer skills including advanced proficiency in MS Office.

You will be a match if you are: 

• Understanding of your client’s and colleague’s needs. 
• Willing to communicate with transparency & honesty.
• Attentive to detail and believe passionately in “Right First Time.” 
• Proactive in everything you do. 
• An advocate of continuous improvement, which is vital to continued success. 
• Adaptable and flexible to meet client and project needs.

The hourly range for this position is $60 - 100.  

If this sounds like you, apply today! 

EEOC 

Transcat is an equal opportunity employer and prohibits discrimination on the basis of any protected status.  All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, domestic violence victim status, gender identity, genetic predisposition or carrier status, marital status, national origin, pregnancy, race, religion, sex, sexual orientation, status as a protected veteran or as a member of any other protected group or activity. 

We will make reasonable accommodations for personal with disabilities to enable them to perform the essential functions of this position unless to do so poses an undue hardship on the organization or a direct threat to health or safety reasonably accommodate individuals to perform the essential functions of this position.