Location: Greater Boston, MA
Extraordinary opportunity to join a dynamic team of technical experts! Validation Technologies, Inc. ( VTI ) is currently looking to identify several exceptional Senior-Level Commissioning/Qualification Engineers to complete our Biopharma team in the greater Boston, MA area. **Level/Title of position contingent on experience and expertise**
These are high-impact and strategic roles within our global organization. One in which a great deal of success will be determined by the Senior C om missioning Engineer’s ability to lead and execute our high-profile validation projects for some of the most prestigious Biopharmaceutical organizations in the world!
Validation Technologies, Inc. ( VTI ) strives to maintain and inspire professional excellence by providing Commissioning, Qualification, IT and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Devices Industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
The Commissioning Engineer Will:
Join a dynamic CQV (commissioning, qualification and validation) team responsible for supporting, implementing, managing and executing high-profile Biotech/Biologics manufacturing capital projects
Have a passion for providing expertise and direction pertaining to various commissioning and qualification activities on behalf of entire VTI organization
Have desire to be hands-on member of high-caliber CQV team responsible for cycle development for various equipment, facilities, utilities and C&Q activities (i.e. cleaning/sterilization processes, etc.) in cGMP biotech manufacturing facility
Have a proven track-record of successfully supporting/ executing high-impact capital projects
The level, compensation and title of position will be contingent on one’s level of experience and expertise
2-15+ years of relevant CQV (commissioning, qualification and validation) industry experience in cGMP/Biotech/Biologics manufacturing/FDA regulated industries
Bachelor’s degree or higher in Engineering, Life Sciences or related discipline (Engineering, Chemical Engineering, Chemistry, Biology, etc.)
Recent and relevant experience related to the Commissioning and Qualification (C&Q) of two or more of the following:
Automation/Controls; Protocol execution; Facilities; Utilities; Process equipment; Requirements development; Planning & schedule development; Design & submittal reviews; Factory & Site acceptance (FAT/SAT) support; Quality oversight/ in-process inspections; Execution coordination/ management; S ystem start-up/ shakedown/ troubleshooting; Functional and performance testing; DCS, BAS/ BMS & PLC Installation Checkout, etc.
Have working knowledge of cGMP/FDA regulations/ ICH guidelines and other international regulatory requirements
Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
Strong interpersonal and communication aptitude, coupled with a high propensity for attention to detail as well as self-motivated initiative
Exceptional technical writing, review and analytical skills in addition to strong verbal communication and presentation skills
Must have strong ability to organize and manage multiple tasks in a fast-paced, but exciting environment
Validation Technologies Offers:
As one of the leading global Commissioning, Qualification, IT and Validation Services organizations, VTI is always looking for innovative, talented and experienced technical professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors.