Senior Validation Engineer
3 weeks ago
Verista is seeking a highly skilled Senior CQV Engineer to join our team. As a Senior CQV Engineer, you will be responsible for managing multiple projects and clients, driving activities as a client-facing leader, and acting as the point of escalation and issue management on client projects.
Key Responsibilities:- Manage multiple projects and clients simultaneously
- Drive activities as a client-facing leader
- Act as the point of escalation and issue management on client projects
- Design validation plans
- Design and execute engineering studies for critical process parameter definition and verification prior to validation
- Verify system drawings, including reviewing and as-built P&IDs and I&C drawings, and verifying electrical schematics with support from an electrical engineer
- Conduct and document impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no-impact systems and functions within complex processes
- Work with equipment OEMs and installation vendors
- Maintain clear, detailed records of qualification and validation, and change control activities for future compliance audits
- Author, edit, and execute technical commissioning, qualification, and validation documentation for standard equipment/systems/software and processes as part of a team, as directed by the project leader
- Run test scripts and document results
- Adhere to project schedules for all assigned activities
- Maintain clear, detailed records of qualification and validation
- Document impact and risk assessments as part of a team
- Complete user interface testing, software verification, and complete alarm testing on automated systems
- Develop, review, and execute testing documentation
- Make recommendations for design or process modification based on test results when executing test scripts
- Have a general understanding of capital equipment implementation and process knowledge
- Understand validation documents, URS, IQ, OQ, PQ
- Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)
- Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV protocols
- Specific experience with 6 reactors (2,000gal+)/receivers, Filter Dryers, Centrifuges, Core Dryers, Powder handling systems, clean rooms, support facilities, and tank farms preferred
- Must be willing to work onsite in Germantown, WI
- 5-7 years of demonstrated CQV experience in GMP regulated environments
- Obvious business maturity and interpersonal skills to effectively communicate and collaborate
- Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
- Proven attention to detail and organization in project work
- Capable of working on assigned tasks without mentorship
- GMP and Good Documentation Practice training (may be completed at onboarding)
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
- Basic skills with EXCEL and PowerPoint
- Strong interpersonal skills and clear communication capabilities
Verista offers a competitive salary, performance-based incentive programs, company-paid life, short-term, and long-term disability insurance, medical, dental, and vision insurance, FSA, DCARE, commuter benefits, supplemental life, hospital, critical illness, and legal insurance, health savings account, 401(k) retirement plan, paid time off, holidays, as-needed sick time, tuition reimbursement, team social activities, employee recognition, employee referral program, paid parental leave, and bereavement.
For more information about our company, please visit us at https://www.verista.com.
-
Senior Validation Engineer
3 weeks ago
Germantown, Wisconsin, United States Verista Full timeJob DescriptionVerista is a leading provider of innovative solutions and services to the life science industry. Our team of experts collaborates with the world's most recognizable brands to solve their business needs and empower growth and innovation within the scientific community.We are seeking a highly skilled Senior Validation Engineer to join our team....
-
Senior Validation Engineer
3 weeks ago
Germantown, Wisconsin, United States Verista Full timeJob DescriptionVerista is seeking a highly skilled Senior CQV Engineer to join our team. As a key member of our team, you will be responsible for managing multiple projects and clients, driving activities as a client-facing leader, and acting as the point of escalation and issue management on client projects.Key Responsibilities:Design and execute validation...
-
Pharmaceutical Validation Engineer
1 day ago
Germantown, Wisconsin, United States Verista Full timeJoin Verista's Team of ExpertsAt Verista, we empower growth and innovation within the scientific community by providing innovative solutions and services that enable informed decision-making.As a Validation Specialist - Life Sciences, you will be part of a team that thrives in a collaborative environment and shares our mission to improve lives.Key...
-
Senior PDM Applications Engineer
3 days ago
Germantown, Wisconsin, United States GSC Full timeJob SummaryAs a Senior PDM Applications Engineer at GSC, you will serve as an internal consultant to multiple clients, providing coaching and guidance to PDM team members and evaluating PDM team projects. You will deliver comprehensive post-sales support for GSC's customers regarding SOLIDWORKS PDM and 3D Experience on cloud products, perform the...
-
Senior CNC Programmer
3 weeks ago
Germantown, Wisconsin, United States Veterans Prime, Inc. Full timeJob Title: Senior CNC ProgrammerWe are seeking a highly skilled Senior CNC Programmer to join our team at Veterans Prime, Inc.Job SummaryThe Senior CNC Programmer will be responsible for designing and programming CNC machines to produce high-quality parts. This role requires strong technical skills, attention to detail, and excellent problem-solving...
-
Senior CNC Programmer
3 weeks ago
Germantown, Wisconsin, United States Veterans Prime, Inc. Full timeJob Title: CNC Senior ProgrammerWe are seeking a highly skilled CNC Senior Programmer to join our team at Veterans Prime, Inc. The ideal candidate will have a strong background in plastic injection moldmaking, experience with CAD/CAM software, and excellent problem-solving skills.Key Responsibilities:Model part geometry changes for moldabilityIntegrate...
-
Senior Mold Designer
3 weeks ago
Germantown, Wisconsin, United States Veterans Prime, Inc. Full timeJob Title: CNC Senior ProgrammerWe are seeking a highly skilled CNC Senior Programmer to join our team at Veterans Prime, Inc. The ideal candidate will have a strong background in mold design, programming, and manufacturing.Responsibilities:Modeling and Design: Create and modify part geometry changes for moldability, ensuring optimal design and manufacturing...
-
CQV Engineer
3 weeks ago
Germantown, Wisconsin, United States Verista Full timeJob DescriptionVerista is a leading provider of innovative solutions and services to the life science industry. We empower growth and innovation within the scientific community by partnering with the world's most recognizable brands to solve their business needs. Our team of experts is committed to making an impact every day by delivering high-quality...
-
Quality Assurance Specialist
2 days ago
Germantown, Wisconsin, United States MGS Mfg. Group, Inc Full timeJob DescriptionMGS Mfg. Group, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring product compliance to internal and customer specifications, as well as compliance to MGS processes.The ideal candidate will have a strong background in quality management...
-
Business System Analyst Intern
5 days ago
Germantown, Wisconsin, United States MGS Mfg. Group, Inc Full timeJob OpportunityMGS Mfg. Group, Inc is seeking a highly motivated and detail-oriented Business System Analyst Intern to join our team. As a Business System Analyst Intern, you will assist and support the IT team with a hands-on view to learn the process-oriented side of IT with exposure to requirements and work performed in the analysis, design,...
-
Quality Assurance Manager
2 days ago
Germantown, Wisconsin, United States Talentry LLC Full timeJob Description:Our client is seeking a detail-oriented and experienced Quality Manager to lead the quality team. The ideal candidate has a strong background in quality management systems, process improvement, and ensuring product excellence.Responsibilities:Drive and implement internal Quality process improvements.Deploy and lead the quality strategy,...
-
Mobile Diesel Technician
4 days ago
Germantown, Wisconsin, United States Schneider National, Inc. Full timeJoin Schneider National, Inc. as a Mobile Diesel Technician and take on a challenging role that requires technical expertise and strong problem-solving skills. **Job Summary:** As a Mobile Diesel Technician, you will be responsible for performing on-site maintenance and repairs on trucks, containers, and trailers. You will work independently with minimal...
-
Mobile Diesel Technician
2 weeks ago
Germantown, Wisconsin, United States Schneider National, Inc. Full timeJob Title: Mobile Diesel TechnicianLocation: Germantown, WIShift: 1st ShiftSchedule: FULLTIME; Monday-Friday 7:00 a.m.-3:30 p.m.Job Overview:Work outside a shop as a Mobile Diesel Technician in Germantown.Complete on-site maintenance on trucks, containers, and trailers.Be supplied with a service truck that's stocked with the specialty tools and parts needed...
-
Mobile Diesel Technician
2 hours ago
Germantown, Wisconsin, United States Schneider Full timeJob Title: Mobile Diesel TechnicianJob Summary:We are seeking a skilled Mobile Diesel Technician to join our team at Schneider. As a Mobile Diesel Technician, you will be responsible for performing on-site maintenance on trucks, containers, and trailers. You will be supplied with a service truck stocked with specialty tools and parts to ensure efficient and...
-
Construction Site Manager
4 weeks ago
Germantown, Wisconsin, United States Keller Full timeJob SummaryThe On-Site Supervisor is the primary point of contact between field employees and office personnel, responsible for overseeing the smooth execution of projects from sale to production.Key ResponsibilitiesCoordinate job site scheduling, including equipment, manpower, and subcontractors.Ensure quality control of subcontractors and Keller work...
-
Construction Site Manager
3 weeks ago
Germantown, Wisconsin, United States Keller Full timeOn-Site Supervisor Job SummaryThe On-Site Supervisor is the primary point of contact between field employees and office personnel, responsible for overseeing the smooth execution of projects from sale to production.Why Keller?Keller Inc. is a 100% employee-owned Design/Build General Contractor with a strong commitment to employee satisfaction and growth. We...
-
Maintenance Mechanic
4 weeks ago
Germantown, Wisconsin, United States Gehl Foods Full timeJob SummaryWe are seeking a skilled Maintenance Mechanic to join our team at Gehl Foods. As a key member of our maintenance team, you will be responsible for performing repairs, preventative maintenance, and troubleshooting for all electrical, mechanical, and pneumatic systems to support both production and non-production related equipment.Key...
-
Maintenance Mechanic
4 days ago
Germantown, Wisconsin, United States Gehl Foods Full timeJob Title: 3rd Shift Maintenance MechanicJoin Gehl Foods as a 3rd Shift Maintenance Mechanic and be part of a team that ensures the smooth operation of our production equipment.Job Summary:We are seeking a highly skilled and experienced Maintenance Mechanic to join our team. The successful candidate will be responsible for performing repairs, preventative...
-
Maintenance Mechanic
4 weeks ago
Germantown, Wisconsin, United States Gehl Foods Full timeJob SummaryWe are seeking a highly skilled Maintenance Mechanic to join our team at Gehl Foods. As a key member of our maintenance team, you will be responsible for performing repairs, preventative maintenance, and troubleshooting for all electrical, mechanical, and pneumatic systems to support both production and non-production related equipment.Key...
-
Maintenance Mechanic
4 days ago
Germantown, Wisconsin, United States Gehl Foods Full timeJob OverviewWe are seeking a highly skilled Maintenance Mechanic to join our team at Gehl Foods. As a key member of our maintenance team, you will be responsible for performing repairs, preventative maintenance, and troubleshooting for all electrical, mechanical, and pneumatic systems to support both production and non-production related equipment.Key...