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Senior devops engineer • bend or

Last updated: 2 days ago

Validation Engineer 2

LancesoftBend, OR, US
Full-time +1
Quick Apply

Contractor, CSV/CQV Specialist.Interview Process: Initial Teams interview followed by a panel interview (Teams or onsite;onsite may be required).Immediate need due to a significant CQV validation b... Show more

Project Engineer

Pence ConstructionBend, OR, United States
Full-time

This position qualifies for internal referral.The Project Engineer (PE) is responsible for assisting the projects teams with obtaining, evaluating, coordinating and distributing the information and... Show more

Tax Senior

GpacBend, Oregon, United States
$70,000.00 yearly
Full-time

A reputable Public Accounting firm in the area is looking to add a .This stable and growing firm offers clients valuable knowledge and expertise in tax.Due to the recent growth of the firm, th... Show more

Senior Internal Auditor

St. Charles Health SystemBend, OR, United States
$78,478.00–$116,480.00 yearly
Full-time

Pay range: $78,478 - $116,480 annually, based on experience.This position comes with a comprehensive benefits package that includes medical, dental, vision, a 403(b) retirement plan, and a generous... Show more

Validation Engineer - Bend, OR

Unicon Pharma IncBend, OR, United States
Full-time
Quick Apply

MsoNoSpacing" style="text-align:justify"><b>Title:</b> CSV/CQV Specialist</p> <p class="MsoNoSpacing" style="text-align:justify"><b&... Show more

Senior Municipal Project Manager

Century West EngineeringBend, OR, United States
Full-time

Century West Engineering is seeking a Senior Project Manager with municipal business development, design, and project management experience.As a senior leader responsible for managing a diverse gro... Show more

Remote Mechanical Engineer

Micro1Bend, Oregon, US
Remote
Full-time

AI data lab for training frontier models and evaluating AI agents.Experts contribute their diverse subject matter knowledge across domains such as finance, healthcare, STEM engineering, and more.AI... Show more

Project Engineer I

Southland Industries Inc.Bend, OR, US
Full-time

Are you looking for an opportunity to jump start your career path in project management? If so, Southland Industries’ Project Engineer position is for you! In this role, you will work on exciting, ... Show more

Senior Sales Representative

Alleviation Enterprise LLCBend, OR, US
Full-time

Senior Sales Representative & Training Mentor at Alleviation – Lead, Inspire, Educate, and Succeed.Alleviation: Cultivating Leadership and Expertise.At Alleviation, we distinguish ourselv... Show more

Professional Electrical Engineer -MEP

PrideStaffBend, OREGON, US
Permanent

Central Oregon and nationally, has an open role for a Professional Electrical Engineer for the MEP / A&E industry.This role will encompass electrical system design for commercial, industrial and la... Show more

Senior Asset Management Consultant

AMCLBend, Oregon, United States
$140,000.00 yearly
Full-time

Senior Asset Management Consultant.The role will require in-person meetings at various client sites.The role may support projects across the U.Asset Data Analytics and Reporting:.Interpret complex ... Show more

Senior Environmental Engineer

Serán BioScienceBend, Oregon, United States, 97701
Full-time

Serán Bioscience, LLC is a solid dosage pharmaceutical contract development and manufacturing organization looking for a Senior Environmental Engineer to lead environmental compliance, sustainabili... Show more

Certification Engineer

Epic AircraftBend, OR, US
Full-time

Epic Aircraft is a leading manufacturer of high-performance, all-carbon fiber, single-engine turboprop aircraft.Our commitment to innovation, safety, and excellence has established us as a key play... Show more

Assurance Senior Manager

SorrenBend, OR, United States
$125,000.00–$170,000.00 yearly
Full-time

Sorren Assurance Engagement Leader.Our Firm Sorren is a top 50 national advisory firm that blends deep expertise with a human-first approach.We don't just work with numberswe work with people, buil... Show more

Tax Senior or Manager

JobotBend, OR, US
$85,000.00 yearly
Full-time

Boutique Bend Firm with a tenured staff! This Jobot Job is hosted by: Emily Bohanon Are you a fit? Easy Apply now by clicking the "Quick Apply" button and sending us your resume.Salary: $85,000 - $... Show more

Senior Territory Sales Representative

TDS TelecomBend, OR, US
$100,000.00 yearly
Full-time

Overview: Ready to Take Your Door-to-Door Sales Career to the Next Level? You’ve mastered the art of connecting with people at the doorstep—now it’s time to turn that experience into a high-earning... Show more

Senior Tax Accountant - CPA

Jones & Roth CPAs and Business AdvisorsBend, OR, United States
Full-time

Position Type Full Time Travel Percentage Negligible Category Experienced CPA.Join the Jones & Roth Team: Where Your Career Thrives!.Are you an experienced tax professional ready to take the next s... Show more

Remote DevOps / Platform Engineer Talent Network - AI Trainer ($70-$150 per hour)

MercorBend, Oregon, US
$70.00 hourly
Remote
Part-time

About Mercor’s talent network** Join our DevOps / Platform Engineer Expert Network to connect with leading AI labs and companies seeking your expertise.This is an open application for future contra... Show more

Senior Advisor

Internal Revenue ServiceBend, OR, United States
Full-time

This is the job title provided above.The following are the duties of this position at the full working level.If this vacancy includes more than one grade and you are selected at a lower grade level... Show more

Senior Tax Analyst

Treasury DepartmentBend, OR, United States
Full-time

The following are the duties of this position at the full working level.If this vacancy includes more than one grade and you are selected at a lower grade level, you will have the opportunity to le... Show more

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Validation Engineer 2

Validation Engineer 2

LancesoftBend, OR, US
2 days ago
Job type
  • Full-time
  • Temporary
  • Quick Apply
Job description

Contractor, CSV/CQV Specialist





Location: Bend, OR (Onsite)


Duration: 6-9 Month Contract


Schedule: Full-time, onsite


Interview Process: Initial Teams interview followed by a panel interview (Teams or onsite;onsite may be required).





Hiring Manager Notes




  • Immediate need due to a significant CQV validation backlog.




  • Strong preference for candidates with analytical laboratory experience.




  • Must be comfortable balancing priorities between CQV and Instrumentation teams.




  • Onsite presence in Bend is required to support instrument qualification and field execution activities.




  • Candidates with both CSV and CQV experience will be highly preferred.









Position Summary





Lonza is seeking a contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV department. This role will provide validation support for analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with both the Instrumentation and CQV teams.





The successful candidate will split time supporting Dawn Bosco's CQV priorities and the Instrumentation team's CSV activities. This individual must be comfortable managing multiple priorities simultaneously, producing high-quality documentation, and working hands-on with laboratory instruments and equipment in a regulated cGMP environment. Because the position supports physical equipment and instrument qualification activities, onsite presence in Bend, Oregon is required.





Key Responsibilities







  • Develop, execute, review, and maintain validation lifecycle documentation, including:





    • Risk Assessments




    • User Requirement Specifications (URS)




    • Design Specifications




    • Traceability Matrices




    • Test Scripts




    • Validation Protocols




    • Discrepancies and Deviations




    • Summary Reports




    • Periodic Review Documentation




    • System Retirement Documentation





  • Support qualification and validation activities for new and existing analytical laboratory instruments, computerized systems, and GMP equipment.




  • Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.




  • Ensure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and Annex 11 requirements.




  • Partner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners to plan and execute validation activities.




  • Prepare and support change controls, impact assessments, deviations, CAPAs, and validation protocols related to GMP equipment, analytical instruments, and computerized systems.




  • Utilize and support the Kneat validation platform, including document creation, workflow routing, approvals, and record closure.




  • Assist with Kneat template development and continuous improvement initiatives.




  • Maintain inspection-ready documentation in accordance with SOPs, GxP requirements, and site procedures.




  • Monitor field execution activities, identify gaps early, drive discrepancy resolution, and escalate issues as appropriate.




  • Split support between the Instrumentation team for CSV activities and the CQV group for qualification execution, documentation updates, and readiness activities.




  • Travel between Bend campus buildings as needed to support laboratory instrument and equipment qualification activities.




  • Perform other duties as assigned.







Required Qualifications





Education: Bachelor's Degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.





Experience




  • Minimum 3-5 years of CQV and/or CSV experience within pharmaceutical, biotechnology, or other regulated industries.




  • Experience supporting analytical laboratory instruments and equipment qualification.




  • Experience working in cGMP-regulated environments.




  • Experience with computerized systems validation and equipment qualification.




  • Experience managing multiple validation projects and competing priorities.




  • Previous backlog remediation or high-volume validation support experience is highly desirable.







Technical Knowledge




  • Proven experience using Kneat validation/documentation software.




  • Strong understanding of GMP documentation requirements and validation practices.




  • Knowledge of:





    • GxP regulations




    • 21 CFR Part 11




    • 21 CFR Parts 210 and 211




    • EU Annex 11




    • Annex 15




    • USP and ASTM standards





  • Understanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.




  • Strong understanding of equipment qualification versus instrument validation requirements.







Key Competencies




  • Excellent technical writing and documentation skills.




  • Strong organization and attention to detail.




  • Ability to prioritize effectively across multiple projects and stakeholders.




  • Proactive problem-solving skills.




  • Ability to work both independently and collaboratively in a regulated environment.




  • Strong communication and cross-functional collaboration skills.




  • Commitment to quality, compliance, and data integrity.







Physical & Environmental Requirements




  • Work within a clean, secure, and regulated GMP environment.




  • Wear required PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.




  • Occasional lifting of up to 50 pounds.




  • Travel between site buildings as needed.




  • Flexible schedule to support project activities.




Job Sumary:
CQV Validation Specialist

Shift: ['cGMP Guidelines', 'Computer System Validation (CSV)', 'CQV']

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