Location: Greater Boston, MA
Exciting opportunity to join our dynamic CQV team comprised of exceptionally talented commissioning/validation professionals within their field. Validation Technologies, Inc. (VTI) is currently looking to identify a Senior-Level Process/Automation Engineer to complete our Biopharma “dream team,” in the greater Boston, MA area.
This is a strategic and critical role within our global organization. One in which a great deal of success will be determined by the Sr. Automation Engineer's ability to drive and execute our high-profile/ prestigious Biopharmaceutical projects!
VTI offers competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment.
Validation Technologies, Inc. (VTI) strives to maintain and inspire professional excellence by providing Commissioning, Qualification, IT and Validation Services to the Pharmaceutical, Biotech, Biologics and Medical Devices Industries. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
The Automation Engineer Will:
- Have a proven track-record of successful project execution as well as experience developing and maintaining manufacturing control applications on various platforms in a cGMP environment
- Join a dynamic validation team responsible for supporting/ implementing/ troubleshooting automation and process control solutions for pharmaceutical biologics manufacturing processes
- Inspire and impact other VTI Team members by providing leadership and guidance
- Author/write and execute a variety of technical documents such as Computer Systems Validation (CSV) Lifecycle documents, including User Requirements (URS), Functional Specifications (FS), Risk Assessments, Validation Plans (VMP), Commissioning and (IQ, OQ, PQ) Qualification protocols, etc.
- Over 5 years of relevant experience in Biotech/Pharmaceuticals industries
- Technical degree in related discipline (Computer Science, Engineering, Life Sciences, etc.)
- Recent and extensive experience related to the validation of automation technologies; such as the majority of the following: programmable logic controller (PLC), distributed control systems (DCS)/ DeltaV, Building Management Systems (BMS), SCADA, Human Machine Interface (HMI), Building Automation (BAS), HVAC control systems, etc.
- Demonstrated understanding and hands-on experience in the preparation of Lifecycle documents as well as hands-on experience integrating/implementing commissioning & qualification of automated systems in FDA regulated industries
- Solid knowledge of process instrumentation, equipment
operation for biologics processing technologies (ie. bioreactors,
chromatography, TFF, Clean in Place (CIP), Steam in Place (SIP), etc.)
- Thorough knowledge of cGMP/FDA regulations and work environment
- Strong interpersonal and communication aptitude, coupled with a high propensity for attention to detail as well as self-motivated initiative
- Must have strong ability to organize and manage multiple tasks in a fast-paced environment
- Passion and willingness to travel regionally/domestically
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 validation 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.