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 2 days 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
2 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
3 days ago
Shift Lead
...Shift Leader As Shift Leader you will oversee the day to day operations of the store. You are expected to oversee the Team Leads and Team Members. As a Shift Leader, you are to ensure that both FOH and BOH are operating according to the proper procedures. A successful...
Suggested
Local area
Shift work
Chick-fil-A
Bend, OR
1 day ago
Shift Lead
$18 - $21 per hour
Opens and closes the store in the absence of store management, including all required systems start-ups, required cash handling, and ensuring the floor and stock room are ready for the business day. Responsible for opening back door of store for deliveries. Completes...
Suggested
Hourly pay
Work experience placement
Seasonal work
Local area
Shift work
Walgreens
Bend, OR
4 days ago
Team Lead
...Job Description Summary 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...
Suggested
Full time
Part time
Casual work
Rack Room Shoes
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 Inc
Bend, OR
4 hours ago
Childcare Team Lead
$22.69 - $25.87 per hour
...Childcare Team Lead The Childcare Team Lead provides leadership for the Kids' Corner program while also serving in a front-line lead role, providing safe and rewarding recreational opportunities for youth, ages 6 months to 8 years. Duties may include but are not...
Part time
Work at office
Shift work
Day shift
Afternoon shift
GovernmentJobs.com
Bend, OR
3 days ago
Lead / Supervisory Transportation Security Officer - No Experience Required forEntry-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
2 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
1 day 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...
Shift work
Night shift
Weekend work
Day shift
Afternoon shift
Weekday work
APCO LLC
Bend, OR
6 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
23 hours 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
23 hours ago
Strategic Procurement Lead
Strategic Procurement Lead|Suterra# Strategic Procurement LeadSuterra | Bend, OR | Logistics/supply chain | Not Applicable | Full-time | Job ID: REF7195GShare* Email## Company Description**Join the Team Powering the Future of Sustainable Agriculture****Bend, OR | Onsite...
Full time
Work at office
The Wonderful Company LLC
Bend, OR
3 days 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
1 day 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...
Shift work
St. Charles Health System
Bend, OR
3 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
2 days ago
Certified Veterinary Technician, Lead
$30 - $35 per hour
...Lead Certified Veterinary Technician (CVT) Central Oregon Animal Hospital | Bend, OR Central Oregon Animal Hospital is seeking an experienced Lead Certified Veterinary Technician to join our team in Bend, Oregon. Since 1972, our hospital has proudly served the...
Full time
Flexible hours
Shift work
Central Oregon Animal Hospital
Bend, OR
a month 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
23 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
23 hours 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
14 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
2 days 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
3 days 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
3 days 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
All shifts
Flexible hours
Shift work
Day shift
Afternoon shift
Buckle LLC
Bend, OR
1 day ago
Team Captain Endzone & Loyalty (Front End)
...coachable, accountable, collaborative, and trustworthy, this is the place for you. Win with us every time you step onto the floor. Lead the athlete experience by coaching teammates and driving engagement in loyalty programs and services. As a Team Captain Endzone &...
DICK'S SPORTING GOODS INC
Bend, OR
1 day ago
Bonneville Power Administration (BPA) Client Team Leader
$156k - $249.6k
...power market. What You'll DoKey Responsibilities:BPA Client Leadership Serve as senior sponsor and relationship owner for BPA Lead the BPA Client Team and coordinate cross-business unit delivery Manage the overall BPA client experience and long-term...
Contract work
Work at office
Local area
Flexible hours
David Evans and Associates
Bend, OR
1 day ago
Store Leader
$71k - $92k
...story at the retail store level by executing on consumer experience program initiatives, Visual Merchandising and Visual Standards. Lead Associate Engagement by fostering a positive, collaborative team environment where associates can bring their best to work each and...
Work experience placement
Work at office
Local area
Carhartt
Bend, OR
3 days ago
AE - Merchandise Leader (Part-Time)
...participate in store contests for the chance to win FREE merchandise and other exclusive prizes. About Us: American Eagle is a leading American jeans and apparel brand, the go-to destination for casual style, embraced by generations of youth since 1977. We are...
Full time
Part time
Casual work
Seasonal work
Local area
Flexible hours
Shift work
Weekend work
Afternoon shift
Early shift
American Eagle Outfitters
Bend, OR
1 day ago
Multi-Unit Leader
Description: SONIC is all about having fun while you work and gaining a sense of accomplishment along the way. Not only do you work with fantastic people, you'll get great pay, flexible hours and a cool uniform. As a Sonic Multi-Unit Leader, you will be managing...
Local area
Immediate start
Flexible hours
Shift work
Night shift
Sonic
Bend, OR
4 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
3 days ago

Do you want to receive more vacancies?

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