Sr. Validation Engineer - Utilities and Facilities

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious Senior Validation Engineer looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.

We are looking to staff a Validation Engineer to be responsible for performing the validation of facilities and utilities systems and equipment for projects within San Diego County. This includes developing validation master plans with minimum supervision, preparing and executing protocols independently, analyzing test results, and preparing technical reports.

Contribute directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing. Collaborates with cross-functional project teams.

REQUIREMENTS: 

• Experienced with the validation of biotech utilities
• Experienced with the validation of biotech facilities and cleanrooms                                                  
• Experienced with the validation of the downstream manufacturing process: Compressed Air HEPA Filters, CO2 Gas Systems, HVAC, USP, DeltaV, Installation, Qualification, Relative Humidity, WFI Distribution Loop, Building Management System, Differential Pressure, ISO Rating, RODI Distribution, Water For Injection, Clean Dry Air, RODI Skid, Ultraviolet Testing, Clean Steam Distribution, Dynamic Testing, Room Temperature, Clean Steam Generator, Clean Room Sample Sites, Chilled Water, Endotoxin Testing, Operational Qualification, Static Testing, EMPQ, Performance Qualification, Valve Array, Clean in Place, Plant Steam and Clean Room

QUALIFICATIONS:

• 5+ years of relevant Validation (commissioning, qualification, and validation) industry experience in cGMP/Biotech/Pharmaceutical Manufacturing/FDA regulated industries
• Bachelors degree or higher in Engineering, Life Sciences, or related discipline (Engineering, Chemical Engineering, Chemistry, Biology, etc.)
• Advanced level of knowledge of ISPE Baseline Guide Chapter 5 for C&Q
•  Advanced level of knowledge of ASTM E2500
•  Advanced level of proficiency in commissioning, qualification and validation support for multiple downstream biotech processes and equipment including protocol (IQ/OQ/PQ) generation and execution
• Advanced of level of knowledge of cGMP/FDA regulations/ ICH guidelines and other international regulatory requirements
• Advanced level of proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
• Superb level of technical writing, review, and analytical skills in addition to strong verbal communication and presentation skills
• Must excel in the ability to organize and manage multiple tasks in a fast-paced environment
• Must be a team player with a great attitude and a will to learn new technologies to achieve a high level of success in a multi-discipline, multi-cultural, global, future driven, engineering environment

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device 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.

VTI Life Sciences provides contract services to a wide variety of clients around the world. For a typical service contract, it is necessary for VTI employees to travel to project sites and perform a variety of validation and laboratory work without the assistance of another worker or special accommodations. To perform these services safely and effectively, the following minimum physical requirements are indicated for the position offered:

1. COVID-19 Vaccination.                                                                                                                                               (a) Must be fully vaccinated against COVID-19. Including booster shot.

2. Physical Requirements                                                                                                                                               (a) Must be able to read a typical computer screen, vendor operation and maintenance manuals, client SOPs,  nameplate data and hazard/safety signs.                                                                                                           (b) Must be able to hear human voice with normal background noise.                                                                     (c) Must be able to hear fire alarms, normal paging systems and buzzers.                                                               (d) Must be able to effectively operate a computer keyboard or touch screen and type at a rate of speed to support project deliverables in a timely manner as scheduled.                                                                                       (e) Must be efficient in the use of MS Office products and software to support project deliverables in a timely manner as scheduled.                                                                                                                                                     (f) Must be able to ascend and descend a 12 ft. ladder.                                                                                             (g) Aseptic technique qualification is necessary. Must be able to don standard clean room attire: bunny suit, lab coat, gloves, head cover, and booties, without contaminating garments, gloves, or the facility. Must be able to work within drug and device manufacturing clean rooms and workstations.                                                                   (h) Must be able to drive a car.                                                                                                                                   (i) Must be able to travel on airliners, use taxis, buses, and rental cars.