DPS Engineering Boston , MA 02298
Posted 4 days ago
Summary
The CQV Engineer will report to the CQV Manager to execute Commissioning, Qualification and Validation activities for a client in the Boston, MA area. The ideal candidate will be responsible for executing CQV activities at the new facility and to collaborate with Global Engineering, Facilities Operations, GIS, QA and PMO throughout the life cycle of the project.
Key Responsibilities
Develop and execute Analytical Instrument CQV Test Plan and Protocols.
Conduct Analytical Instrumentation Qualifications in accordance with USP<1058> and SOPs.
Conduct Automation Assessments to ensure compliance with 21 CFR Part 11.
Coordinate with vendor personnel to schedule and execute of test plans.
Coordinates with the construction team and operations to safely and effectively schedule CQV activities.
Effectively works with cross departmental stakeholders, PMO, GIS, EH&S, Global Security, design teams, EHS and QA.
Completes assigned training and ensures that they are 100% compliant 100% of the time.
Ensure that all CQV activities align with the current SOPs, global standards and cGMP guidelines.
Supports right-the-first time culture for all documents distributed across the organization. Ensure the Global Engineering reputation and partnership is flourished with the cross-functional teams.
Other duties as assigned
Skills & Qualifications
Demonstrated ability to safely execute CQV activities in a dynamic fast paced environment.
Experience developing and executing CQV protocols in a GMP Analytical Laboratory.
Receptive to change
B.A, B.S. in Engineering or related discipline with 3-5 years of CQV experience or equivalent professional experience.
Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.
Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
Additional Skills Required:
In order to perform a client assignment for DPS successfully, an individual must be able to perform each essential duty to high technical standard. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The Company
DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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DPS Engineering