VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to help support…
Thousand Oaks, California, United States · On-site
Senior+
Senior Validation Lead, CQV / CSV We are seeking a Senior Validation Lead with strong experience supporting GMP qualification and validation programs across manufacturing equipment, facility utilities, QC laboratory syst…
Skills: Commissioning, Qualification, and Validation (CQV), Computer System Validation (CSV), GMP Qualification, FDA Compliance, GAMP 5
Thousand Oaks, California, United States · On-site
$90k–$120k/yr
Senior
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to help support…
Thousand Oaks, California, United States · On-site
Senior
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious industrial automation engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an oppor…
Skills: Computerized Systems Validation, Industrial Automation, Commissioning and Qualification, PLC Programming, HMI
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Full-time
Professional Development, Training, Competitive Compensation, 401k Matching
Posted 14d ago
Apply by Sep 12
~40 hrs/week
Responsibilities
The engineer will lead the technical integration of process equipment, piping, and utilities for an OTC cGMP facility relocation. Responsibilities include managing equipment layouts, overseeing hygienic piping design, and coordinating BIM models to accelerate construction and startup.
Requirements
Requires over 10 years of experience in process facility design or hygienic systems within the pharmaceutical, biotech, or food industries. Proficiency in Revit, Navisworks, and knowledge of ASME BPE and B31.3 standards are essential.
Full job description
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their careers 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 industry.
We are looking for a Senior Process Facilities Engineer to support an OTC cGMP Facility Relocation and Manufacturing Integration Project. The project includes the relocation and integration of existing compounding systems, process piping, filling equipment, packaging lines, clean utilities, and supporting manufacturing infrastructure into a new facility. The project is being executed on an aggressive design-build schedule and will leverage laser scanning, BIM modeling, and prefabrication strategies to accelerate design and construction activities. The selected individual will serve as a key technical resource supporting process equipment layout, utility integration, process piping design, and multidisciplinary coordination throughout design, construction, commissioning, and startup.
PROJECT OVERVIEW Responsibilities The successful candidate will work closely with the Owner, Architect/Engineer, BIM team, construction team, equipment vendors, and GMP consultants to: Process Equipment Layout & Integration
Review and validate owner-provided legacy design documentation and equipment layouts.
Assist with placement and arrangement of compounding, filling, packaging, and utility equipment.
Evaluate operator access, maintenance access, material flow, and future expansion requirements.
Coordinate equipment installation requirements with structural, architectural, mechanical, and electrical systems.
Process Utility & Piping Design
Develop and refine process utility concepts and routing strategies.
Support development and review of PFDs, P&IDs, line lists, and utility requirements.
Design or oversee design of hygienic process piping systems, including: Product transfer systems
Purified Water systems
CIP systems
Compressed air systems
Process waste systems
Apply ASME BPE and hygienic design principles where appropriate.
BIM & Design Coordination
Participate in scan-to-BIM and reality capture review activities.
Utilize laser scan and BIM models to evaluate equipment placement and piping pathways.
Coordinate process systems within Navisworks and multidisciplinary BIM models.
Identify opportunities for prefabrication and reduction of field labor.
Construction & Startup Support
Support review of fabrication drawings and installation details.
Assist with tie-in planning, startup readiness, and commissioning activities.
Participate in design reviews, constructability reviews, and GMP-related discussions.
Support development of documentation required for turnover and qualification activities.
Requirements
10+ years of experience in process facility design, process utilities, or hygienic process systems.
Experience with pharmaceutical, OTC, biotech, food, beverage, dairy, or other hygienic manufacturing facilities.
Working knowledge of: ASME B31.3
ASME BPE
Hygienic piping systems
Process equipment integration
Experience with:
Revit
Navisworks
Plant 3D or similar process design software
Scan-to-BIM workflows
Strong ability to collaborate across engineering, operations, quality, OEM, and construction teams.
Ideal Candidate This role is best suited for an engineer who understands both process systems and facility integration. We are not seeking a traditional piping drafter or a greenfield process designer. We are seeking an experienced engineer who can quickly evaluate an existing facility design, identify high-risk assumptions, optimize equipment and utility integration, and help guide an accelerated facility relocation from design through startup. Experience supporting facility relocations, equipment reinstallation projects, manufacturing modernization projects, or complex process system integrations is highly desirable. 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, a matching 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.
As one of the leading global Commissioning, Qualification, 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. www.validation.org
Related keywords
cGMPPharmaceuticalBiotechnologyMedical DeviceASME BPEASME B31.3Hygienic DesignRevitNavisworksPlant 3DScan-to-BIMBIM ModelingProcess PipingPurified Water SystemsCIP SystemsCompressed Air
VTI is a consulting firm specializing in automation and CQV services to biotech, pharmaceutical, and med device clients.
Industry
Biotechnology
Company size
51-200 employees
Founded
1996
Headquarters
San Diego, California
LinkedIn followers
5,959
VTI Life Sciences is an ISO 9001:2000 Certified Company with the experience, expertise, and commitment to provide the superior service required to meet all of your validation and compliance needs. We offer a full spectrum of services including: computer validation, cleaning validation, process validation, clean room certification, temperature mapping, process equipment and facility qualification, and much more. Dedication to quality, personalized support and the success of your projects are the foundation of our company. VTI Life Sciences has offices located in San Diego, San Francisco, Boston, and China.
Offices: 10815 Rancho Bernardo Road, Suite 120, San Diego, California 92127, US · 10815 Rancho Bernardo Road, Suite 120, San Diego, CA 92127, US · 10815 Rancho Bernardo Road, Suite 120, San Diego, CA 92127, US · 10815 Rancho Bernardo Road, Suite 120, San Diego, CA 92127, US · 10815 Rancho Bernardo Road, Suite 120, San Diego, CA 92127, US
Computer ValidationCommissioning & Qualification (C&Q)Cleaning & Process ValidationProject ManagementAutomation & Control SystemsIT ServicesCalibrationProcess Equipment & Facility QualificationQuality & Regulatory Servicesand Temperature Mapping
VTI is a consulting firm specializing in automation and CQV services to biotech, pharmaceutical, and med device clients.
Industry
Biotechnology
Company size
51-200 employees
Founded
1996
Headquarters
San Diego, California
LinkedIn followers
5,959
VTI Life Sciences is an ISO 9001:2000 Certified Company with the experience, expertise, and commitment to provide the superior service required to meet all of your validation and compliance needs. We offer a full spectrum of services including: computer validation, cleaning validation, process validation, clean room certification, temperature mapping, process equipment and facility qualification, and much more. Dedication to quality, personalized support and the success of your projects are the foundation of our company. VTI Life Sciences has offices located in San Diego, San Francisco, Boston, and China.
Offices: 10815 Rancho Bernardo Road, Suite 120, San Diego, California 92127, US · 10815 Rancho Bernardo Road, Suite 120, San Diego, CA 92127, US · 10815 Rancho Bernardo Road, Suite 120, San Diego, CA 92127, US · 10815 Rancho Bernardo Road, Suite 120, San Diego, CA 92127, US · 10815 Rancho Bernardo Road, Suite 120, San Diego, CA 92127, US
Computer ValidationCommissioning & Qualification (C&Q)Cleaning & Process ValidationProject ManagementAutomation & Control SystemsIT ServicesCalibrationProcess Equipment & Facility QualificationQuality & Regulatory Servicesand Temperature Mapping