Sr. CSV Automation Lead

Intellectt INC

Title: Sr. CSV Automation Lead
Location: Bend, OR
Duration: 12+ months
Rate: $60-65/Hr on W2.

Background: We are seeking an experienced Senior CSV Lead to support a large-scale CAPEX project within a regulated pharmaceutical/biotechnology manufacturing environment. The ideal candidate will possess extensive expertise in Computer System Validation (CSV), Automation, SCADA system, PLCs (Allen Bradley), and Emerson Syncade MES, with a proven track record of leading validation activities for complex manufacturing systems from design through implementation and qualification.

This role requires a hands-on validation professional capable of working independently while collaborating with engineering, automation, manufacturing, quality, and IT/OT teams to ensure systems meet regulatory compliance and business requirements.

Project:
Lead Computer System Validation (CSV) activities for large-scale CAPEX projects throughout the full system lifecycle.
Collaborate with CQ lead and Project Manager to provide status updates
Review & approve CSV lifecycle documentation, including:
o Validation Plans
o System Classification
o System CSV Plan & Report
o Data Integrity Risk Assessments (DIRA)
o User Requirements Specifications (URS)
o Functional Specifications (FS/FDS)
o Configuration Specifications (CS)
o IQ/OQ Protocols
o Traceability Matrices
o Qualification Final Reports
Lead validation efforts for Emerson Syncade MES implementation, configuration, testing, and deployment.
Drive commissioning and validation of Syncade MES applications.
Collaborate closely with Automation, Engineering, Manufacturing, Quality Assurance, and IT/OT teams during project execution.
Validate automation systems integrated with Allen Bradley PLCs and related manufacturing equipment.
Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity principles, and procedures.
Manage and document Software Development/design Changes (SDC) throughout the SDLC in accordance with organizational procedures.
Participate in FAT, SAT, commissioning, startup, and qualification activities as required.
Serve as CSV SME and provide technical guidance to remote doc preparation team and CQ/CSV throughout project duration.
Generate monthly KPIs for CQ/CSV leadership team.

Apply

Vacancy posted 1 day ago

Similar jobs that could be interesting for youBased on the Sr. CSV Automation Lead in Bend, OR vacancy

Senior Healthcare Compliance & Risk Leader
Waterfall Community Health Center seeks a Compliance Officer to lead and administer its Corporate Compliance Program, ensuring adherence to federal and state laws, HRSA Health Center Program requirements, FTCA, and grant conditions. Reporting to the CEO and Board access...
Senior
Wfall
Bend, OR
5 days ago
Project End-to-End (E2E) Quality Control Lead
...Relocation assistance is available for eligible candidates and their families, if needed.This role offers an exciting opportunity to lead Quality Control (QC) project activities supporting laboratory development, expansion, and operational readiness at Lonza’s growing...
Suggested
Full time
Worldwide
Relocation package
Lonza
Bend, OR
1 day ago
Senior Infrastructure Project Manager
...Senior IT/OT Infrastructure Project Manager Lead the strategic delivery of IT and OT infrastructure for the state-of-the-art Project... ...Blockbuster production facility, driving digital integration, automation, and long-term operational intelligence. This is a fully...
Senior
Hourly pay
Lonza
Bend, OR
5 days ago
The Herb Center Bend - Cannabis Dispensary - Shift Lead - Bend
...Role Golden Grail Group is looking for passionate and dependable individuals to join The Herb Center Bend dispensary team as Shift Lead (Lead Product Specialists). In this customer-facing role, you'll help guide guests through their cannabis experience with compassion...
Suggested
Shift work
Night shift
Weekend work
Day shift
Afternoon shift
Weekday work
APCO LLC
Bend, OR
4 days ago
Lead Sterile Processing Technician
...LeadReports To Position: Sterile Processing Manager or SupervisorDepartment: Sterile ProcessingPosition Overview: The Sterile Processing Lead at St. Charles Health System (SCHS) is responsible for coordinating shift operations to meet procedural departments' needs and...
Suggested
Shift work
St. Charles Health System
Bend, OR
1 day ago
Childcare Team Lead
...benefits, please click here. Open until Filled: First review of candidates will be Tuesday 7/21/2026 About the job The Childcare Team Lead provides leadership for the Kids' Corner program while also serving in a front-line lead role, providing safe and rewarding...
Part time
Work at office
Shift work
Day shift
Afternoon shift
Bendparksandrec
Bend, OR
4 days ago
Store Leadership Lead: Merchandising & Front End
Ross Stores is seeking an Area Supervisor to lead a specific store area, ensuring both operational success and an excellent customer shopping experience. The successful candidate will manage Associates, maintain store presentation, and uphold safety standards. Ideal candidates...
Flexible hours
Afternoon shift
Ross Stores
Bend, OR
3 days ago
Team Lead
...Team Lead The Team Leader is responsible for supporting Store leadership, delivering Legendary Service, coaching Team Members, and owning assigned sales-floor presentation areas. In the updated operating model, Team Leaders are expected to be top selling Team Members...
Full time
Part time
Flexible hours
Shift work
Night shift
Weekend work
Tractor Supply
Bend, OR
5 days ago
Strategic Procurement Lead
Job Description Bend, OR | Onsite | Strategic Procurement Lead. The Strategic Procurement Lead will provide insight, analysis and leadership for the supply chain management team to ensure a robust supply of materials and components to launch and sustain new and existing...
Work at office
Suterra
Bend, OR
5 days ago
Industrial Wastewater Program Lead - Oil, Gas and Chemicals Practice
$170k - $230k
...and planning through design and construction monitoring and operations. HDR is searching for an Industrial Wastewater (IWW) Program Lead - Oil, Gas, and Chemicals Practice. Candidates should have a minimum of 10 years of direct experience with industrial water/wastewater...
Full time
Temporary work
Part time
For contractors
HDR
Bend, OR
4 days ago
Team Lead
...Team Lead The Team Lead assists in supervising and managing all day-to-day store operations while ensuring that 100% compliance exists with all established Company policies and procedures. Provides leadership, guidance and training to the store staff via direction...
Full time
Part time
Rack Room Shoes
Bend, OR
1 day ago
Lead / Supervisory Transportation Security Officer - No Experience Required for Entry-Level TSA Careers
$25 - $50 per hour
...Role Overview TSA is accepting applications for Lead and Supervisory Transportation Security Officers at airports in Bend. These roles are ideal for individuals looking to step into leadership positions within airport security operations. TSA provides training to prepare...
Shift work
Night shift
Weekend work
Airport Security Careers
Bend, OR
more than 2 months ago
Industrial Wastewater Program Lead, Oil, Gas & Chemicals
$170k - $230k
HDR is seeking an Industrial Wastewater (IWW) Program Lead for its Oil, Gas, and Chemicals Practice. The role requires 10+ years of experience in industrial water/wastewater treatment systems, and the ability to lead teams in complex engineering projects. Responsibilities...
HDR
Bend, OR
4 days ago
Store Lead
...Store Lead As a Store Lead, you will partner with your Store Manager to support store team members to achieve sales performance expectations through active coaching, development of a team selling environment, and operational excellence when you are the manager on duty...
Work at office
Shift work
Tailored Brands
Bend, OR
5 days ago
Executive Director, Lifecycle Lead
...Executive Director, Lifecycle Lead About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases Industry Biotechnology Type Privately Held, VC-backed Founded 2018 Employees 51-200 Funding $101-$200 million...
Confidential
Bend, OR
4 days ago
Lead Installer - HVAC
$40 - $50 per hour
...Job Description Job Description Lead HVAC InstallerAccuAir Heating & CoolingCentral Oregon$40 - $50 per hour + Full Benefits Lead a Team • Take-Home Company Vehicle • Year-Round WorkAre you an experienced HVAC Installer who is ready to step into a leadership role...
Hourly pay
Work at office
Monday to Friday
AccuAir, Inc.
Bend, OR
12 days ago
Night Shift Lead Sandwich Artist
$16 - $17 per hour
...Job Description Job Description Hiring for a late night shift closing lead Pay between $16.00- $17.00 plus tips Full Time or Part Time short or long shifts with shifts starting times early as 4pm or as late as 7pm and ending at 1:30am As part of the Subway...
Full time
Part time
Shift work
Night shift
Afternoon shift
Early shift
Subway - 6250-0
Bend, OR
21 days ago
Federal Water Project Manager / SR PM
...difference in people’s lives. This isn’t just a job, it's a chance to lead change, drive progress, and leave a lasting legacy.HDR is seeking... ...to our federal clients.In the role of Federal Project Manager / Sr PM, we'll count on you to:Lead, direct, and oversee all phases of...
Senior
Contract work
HDR
Bend, OR
3 days ago
Plant Transformation Leader - Global Operations
...the Force Driving Global Operational ExcellenceAre you ready to lead large-scale transformation across a global manufacturing... ...projects across multiple sites, from manufacturing redesign and automation to product flow optimization and training system transformation...
Full time
The Wonderful Company
Bend, OR
9 hours ago
Lead HVAC Installer
Residential HVAC Installation LeadSafely operate company vehicleWork well with customers, co-workers and other sub-contractorsProvide direction and on the job training to install apprentice/helpersInstallation of ductwork in a neat & professional mannerKeep job site and...
Comfort Flow Heating
Bend, OR
1 day ago
Lead Teacher & Mentor for Early Learners
KinderCare Learning Companies is seeking a Lead Teacher to guide classrooms, implement the curriculum, and create a nurturing, safe environment for young learners. You will collaborate with parents and center staff to support enrollment and ongoing accreditation, while...
KinderCare Education LLC
Bend, OR
1 day ago
Leader In Training (Full-Time)
...Manager, advanced product search, iPad apps, etc. Maintain and build good Guest relationships to develop a client based business Lead by example with a high level of showmanship, excellent customer service and attentiveness Recognize and communicate Guest Levels...
Hourly pay
Full time
Work at office
Local area
All shifts
Flexible hours
Shift work
Day shift
Afternoon shift
Buckle LLC
Bend, OR
3 days ago
LEAD Case Manager/Peer Support Specialist
$30 per hour
...epidemic since our first clinic opened in 2012. With more than 80 clinics across 9 states, we continuously strive to be the nation's leading provider of low-barrier evidence-based treatment for opioid use disorder. We are looking for a Case Manager/Peer Support...
Hourly pay
Full time
Temporary work
Live in
Monday to Friday
Ideal Option and Ideal Balance
Bend, OR
1 day ago
Prepared Foods Team Leader
$25.1 - $42.5 per hour
Prepared Foods Team Leader Provides overall leadership to the Prepared Foods team. Responsible for all aspects of daily operations including profitability, expense control, buying, merchandising, labor, regulatory compliance and special projects as assigned. Accountable...
Hourly pay
Full time
Part time
Seasonal work
Work at office
Flexible hours
Night shift
Whole Foods
Bend, OR
2 days ago
Sr Financial Analyst
...scenarios and metrics that are used to make strategic company decisions. They are also responsible for reviewing the work of others, and leading and mentoring other team members, sometimes owning and administering projects beginning to end. Working on multiple projects at a...
Senior
Work at office
Flexible hours
Les Schwab Tire Center
Bend, OR
1 day ago
Senior Validation Engineer
...across equipment qualification, computerized systems validation (CSV), documentation, and field execution activities. Candidates... ...and EU Annex 11 . Partner with QC, Instrumentation, Engineering, Automation, QA, and system owners to plan and execute validation activities...
Senior
For contractors
Aequor
Bend, OR
2 days ago
Tax Senior
$80k - $100k
Tax Senior | Hybrid | $80,000 - $100,000Position OverviewWe are seeking an experienced Tax Senior to lead client engagements and provide high-quality tax compliance and planning services. In this hybrid role, you will be responsible for preparing and reviewing federal...
Senior
CyberCoders
Bend, OR
1 day ago
Senior Tax Analyst
Large Business And International(lb&i)What is Large Business and International(lb&i)? A description of the business units can be found at are to be filled in following area(s): Withholding Exchange and International Individual Compliance (WEIIC), Offshore Compliance Initiative...
Senior
US Government Jobs
Bend, OR
4 days ago
Track Supervisor
Job TitleEssential Duties And Responsibilities:Ensure that all track personnel perform their assigned duties safely, effectively and professionallyEnsure that the daily attendance log is completed by all staff membersCoordinate with Assistant and General Managers regarding...
K1 Speed
Bend, OR
1 day ago
Senior Economist
Large Business & International DivisionWhat is Large Business & International (LB&I) Division?A description of the business units can be found at: are to be filled in following area(s):Director Treaty and Transfer Pricing Operations (TTPO).Review the additional information...
Senior
US Government Jobs
Bend, OR
1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Sr. CSV Automation Lead. Be the first to apply!