Senior Engineer, Validations
3 weeks ago
Summary:
The Senior Validations Engineer will fill an important need at DiscGenics through helping the company to be ready for commercial GMP production and providing support to validation technicians. This position will also oversee supplier/vendor validation efforts as needed and representing DiscGenics’ standards of quality and engineering.
The Senior Validations Engineer will work with all aspects and departments within the company, being exposed to and supporting laboratories (R&D, QC, microbiology) facilities (ISO 5 through 8 and CNC), clean/sterile utilities, quality systems and databases (CMMS and ERP and Building Automation Systems), and production operations (upstream, downstream, and final fill / packaging).
The Senior Validations Engineer will help support potential vendor and/or contractor validation services and will be able to touch upon some supervisory activities of outside consultants.
Essential Duties and Responsibilities:
Technical lead on validation of autoclaves, steam generators, bioreactors, filler/labeler, databases, and new lab/facility.
Support qualification of laboratory instruments for QC and Microbiology.
Support/Lead media fill (aseptic simulations) for sterile fill/finish operations
Mentor validation technicians in their assigned validation and qualification and commissioning efforts of facility/utility/equipment.
Support development of validation program and validation governing SOPs and templates for standard efforts.
Draft validation protocols, and review validation technician’s protocols.
Review and approve validation technician’s summary reports.
Support validation management in planning for and look ahead during Validation Project Plan development.
Support process engineer efforts for pre-validation, risk assessment, and quality by design efforts.
Support process validation (PPQ) and PQ’s including mixing studies, freezing/thaw studies, equipment cleaning studies, facility cleaning studies.
Write Validation Project Plans (VPPs) for groups of systems to bring a facility online for startup and new product commercial launch.
Other duties as assigned
Job Requirements:
Must have 5-10 years of experience in validation or a pharmaceutical/biologics/cell therapy facility.
Experience with analytical QC/Microbiological instruments and tests in a GLP/GMP environment and is familiar with new equipment qualification.
Exposure to facilities/utilities/equipment in a GxP environment and is familiar with qualification of various equipment.
Independence and creative problem-solving abilities.
Ability to handle highly confidential business information.
Exceptional time management and multi-tasking skills.
Team leadership skills and team player.
Adheres to and leads with the Company Values of Integrity, Innovation, Accuracy,
-
Senior Engineer, Validations
2 months ago
Salt Lake City, United States DISCGENICS INC Full timeJob DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary: The Senior Validations Engineer will fill an important need at DiscGenics through helping the...
-
Validations Engineer
2 months ago
Salt Lake City, United States DISCGENICS INC Full timeJob DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary: The Validations Engineer will fill an important need at DiscGenics through helping the company...
-
Validations Engineer
3 weeks ago
Salt Lake City, United States DISCGENICS INC Full timeJob DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary: The Validations Engineer will fill an important need at DiscGenics through helping the company...
-
Structural Engineer
8 hours ago
Salt Lake City, United States CHEMICAL & INDUSTRIAL ENGINEER Full timeJob DescriptionJob DescriptionDescription:C&I Engineering is looking for a talented and driven individual to join our team!About the opportunity: Civil Structural EngineerWe are currently seeking a full-time Civil Structural Engineer to help us achieve our company mission. This person will be part of the Civil/Structural team, which is responsible for...
-
Staff Structural Engineer
3 weeks ago
Salt Lake City, United States CHEMICAL & INDUSTRIAL ENGINEER Full timeJob DescriptionJob DescriptionDescription:C&I Engineering is looking for a talented and driven individual to join our team!About the opportunity: Staff Structural EngineerWe are currently seeking a full-time Staff Structural Engineer to help us achieve our company mission. This person will be part of the Civil/Structural team, which is responsible for...
-
Field Engineer
4 days ago
Salt Lake City, United States Collins Engineer Full timeOverview Collins Engineers, Inc., a leader in the transportation, marine, construction, and land development industries, is looking for a motivated, self-starter to join our Salt Lake City team as a Field Engineer. This role will provide the opportunity to work on construction projects. There will also be work in the field and regional travel. The...
-
Structural Project Engineer II
2 weeks ago
Salt Lake City, United States Collins Engineer Full timeOverview Since opening our doors in 1979, Collins Engineers, Inc. has provided engineering services in structural and transportation analysis and design. Today, Collins is an ENR Top 500 Design Firm that continues to grow our multi-disciplined firm by providing design and analysis services coupled with field experience to the transportation, marine,...
-
Staff Electrical
2 weeks ago
Salt Lake City, United States CHEMICAL & INDUSTRIAL ENGINEER Full timeJob DescriptionJob DescriptionDescription:C&I Engineering is looking for a talented and driven individual to join our team!About the opportunity: Senior/Staff Electrical EngineerC&I is an employee-owned, full-service engineering design firm providing engineering/design/project management and procurement services to various clients in oil & gas, food &...
-
Staff Electrical
2 weeks ago
Salt Lake City, United States CHEMICAL & INDUSTRIAL ENGINEER Full timeJob DescriptionJob DescriptionDescription:C&I Engineering is looking for a talented and driven individual to join our team!About the opportunity: Senior/Staff Electrical EngineerC&I is an employee-owned, full-service engineering design firm providing engineering/design/project management and procurement services to various clients in oil & gas, food &...
-
Staff Electrical
1 month ago
Salt Lake City, United States CHEMICAL & INDUSTRIAL ENGINEER Full timeJob DescriptionJob DescriptionDescription:C&I Engineering is looking for a talented and driven individual to join our team!About the opportunity: Senior/Staff Electrical EngineerC&I is an employee-owned, full-service engineering design firm providing engineering/design/project management and procurement services to various clients in oil & gas, food &...
-
Staff Electrical
3 weeks ago
Salt Lake City, United States CHEMICAL & INDUSTRIAL ENGINEER Full timeJob DescriptionJob DescriptionDescription:C&I Engineering is looking for a talented and driven individual to join our team!About the opportunity: Senior/Staff Electrical EngineerC&I is an employee-owned, full-service engineering design firm providing engineering/design/project management and procurement services to various clients in oil & gas, food &...
-
Staff Piping Engineer
4 weeks ago
Salt Lake City, United States CHEMICAL & INDUSTRIAL ENGINEER Full timeJob DescriptionJob DescriptionDescription:C&I is looking for a talented and driven individual to join our team!About the opportunity: Staff Piping EngineerWe are currently seeking a Staff Piping Engineer to help us achieve our company mission. The Plant Design team is responsible for preparing studies, sketches, drawings and models of equipment arrangements...
-
Staff Piping Engineer
1 month ago
Salt Lake City, United States CHEMICAL & INDUSTRIAL ENGINEER Full timeJob DescriptionJob DescriptionDescription:C&I is looking for a talented and driven individual to join our team!About the opportunity: Staff Piping EngineerWe are currently seeking a Staff Piping Engineer to help us achieve our company mission. The Plant Design team is responsible for preparing studies, sketches, drawings and models of equipment arrangements...
-
Staff Piping Engineer
3 weeks ago
Salt Lake City, United States CHEMICAL & INDUSTRIAL ENGINEER Full timeJob DescriptionJob DescriptionDescription:C&I is looking for a talented and driven individual to join our team!About the opportunity: Staff Piping EngineerWe are currently seeking a Staff Piping Engineer to help us achieve our company mission. The Plant Design team is responsible for preparing studies, sketches, drawings and models of equipment arrangements...
-
Senior Validation Engineer
2 weeks ago
New City, United States GBA Full timeSenior Validation Specialist - Life Sciences Group COMPI is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior Validation Engineer to join our growing team. COMPI differentiates itself through...
-
Senior Validation Engineer
2 weeks ago
New City, United States Gahagan & Bryant Associates Inc Full timeSenior Validation Specialist - Life Sciences Group COMPI is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior Validation Engineer to join our growing team. COMPI differentiates itself through...
-
Senior Validation Engineer
3 weeks ago
New City, United States Compli Full timeJob DescriptionJob DescriptionSenior Validation Specialist – Life Sciences GroupCOMPI is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior Validation Engineer to join our growing team. COMPI...
-
Senior Validation Engineer, Prototyping
1 week ago
Foster City, California, United States Zoox Full timeWe are inventors, builders, and doers, passionate and purposeful in the work we do. We have a once-in-a-century opportunity to reinvent personal transportation—and we need your help. The Zoox Prototyping Team is responsible for unblocking the intricacies of Autonomous Mobility. Our team serves as a technical hub to resolve any challenges in engineering to...
-
Senior Project Engineer Diver
1 month ago
Salt Lake City, United States Marine Solutions, Inc. Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Are you a talented Senior Project Engineer Diver seeking a rewarding new opportunity within a dynamic and emerging company? Marine Solutions has recently opened our office in Salt Lake City, UT, and we're actively looking...
-
Senior Project Engineer Diver
3 weeks ago
Salt Lake City, United States Marine Solutions, Inc. Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Are you a talented Senior Project Engineer Diver seeking a rewarding new opportunity within a dynamic and emerging company? Marine Solutions has recently opened our office in Salt Lake City, UT, and we're actively looking...