Validation & Engineering Group USA, Inc.
(V&EG USA) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Construction Engineer / Manager
Responsibilities:
Responsible for the overall startup of facilities and utilities systems of a new building used to manufacture FDA regulated products.
Ensure that the design and installation of facilities meet all regulatory requirements.
Work with vendors and construction teams to coordinate completion of installation and start up work.
Confirm that their scope of work was completed in accordance with requirements.
Verify that all systems are operational and safe to be energized.
Responsible for first time energizing and startup of new equipment.
Test and confirm that BMS and Safety Systems are operational and comply with requirements.
Confirm mechanical completion of facilities, utilities, infrastructure, and production systems.
Confirm that systems are ready for C&Q phase and complete corresponding release to Validation/QA department.
Creation and/or execution of Risk Assessments, Impact Assessments, SATs, and verification protocols, among others.
Issuance and management of discrepancies and deviations.
Responsible to close Punchlist items before Validation phase is started.
Communicate progress on an established team meeting schedule; promptly escalating any challenges/delays that may require additional support to resolve and remain on schedule.
Ability to work independently while maintaining communication with all team members.
Requires teamwork, leadership, and influencing skills with a strong focus on customer service.
Exposure to typical manufacturing, laboratory, mechanical and warehouse environments.
Qualifications:
Bachelor’s degree in science or engineering.
Minimum of 5 years of experience as a hands-on engineer/scientist working in construction and startup of FDA regulated facilities.
Have substantial experience with commissioning and qualifications.
Excellent communications skills (oral and written) in English.
Excellent technical writing skills.
Must be proficient using MS Windows and Microsoft Office applications.
Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
Able to work in a construction/startup environment.
Available to work extended hours, possibility of weekends and holidays, if needed.
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