The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and ...
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and ...
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and ...
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and ...
Validation Engineer
Fort Worth, TX · On-site
Validation Engineer Location: Fort Worth, TX (Local candidates only) Travel: Required - Alabama (3 ... This role will focus on supervising and coordinating Performance Qualification (PQ) execution ...
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Validation Engineer
Fort Worth, TX · On-site
Validation Engineer Location: Fort Worth, TX (Local candidates only) Travel: Required - Alabama (3 ... This role will focus on supervising and coordinating Performance Qualification (PQ) execution ...
Coordinates and executes validation change control and preparation of draft protocols, reports and data tables. * Maintains all documentation pertaining to validation. * May assist in developing ...
Coordinates and executes validation change control and preparation of draft protocols, reports and data tables. * Maintains all documentation pertaining to validation. * May assist in developing ...
Validation Engineer
Raleigh, NC · On-site
Alliance Biotech Solutions is currently hiring multiple Cleaning Validation Engineers to supports the execution and coordination of cleaning validation activities across manufacturing equipment and ...
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Validation Engineer
Raleigh, NC · On-site
Alliance Biotech Solutions is currently hiring multiple Cleaning Validation Engineers to supports the execution and coordination of cleaning validation activities across manufacturing equipment and ...
Validation Engineer
La Verne, CA · On-site
Coordinates and executes validation change control and preparation of draft protocols, reports and data tables. * Maintains all documentation pertaining to validation. * May assist in developing ...
Validation Engineer
La Verne, CA · On-site
Coordinates and executes validation change control and preparation of draft protocols, reports and data tables. * Maintains all documentation pertaining to validation. * May assist in developing ...
Validation Engineer
Caguas, PR · On-site
Hands-on role focused on protocol execution, technical troubleshooting, and direct coordination ... Support the full Validation Life Cycle: planning, URS/FRS, risk assessment (FMEA), RTM, execution ...
Validation Engineer
Caguas, PR · On-site
Hands-on role focused on protocol execution, technical troubleshooting, and direct coordination ... Support the full Validation Life Cycle: planning, URS/FRS, risk assessment (FMEA), RTM, execution ...
Validation Analyst
Anasco, PR · On-site
$30 - $31/hr
Plans, coordinates, and participates in a compliant validation process for computer and/or automation systems which require formal validation documentation under appropriate regulatory requirements ...
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Validation Analyst
Anasco, PR · On-site
$30 - $31/hr
Plans, coordinates, and participates in a compliant validation process for computer and/or automation systems which require formal validation documentation under appropriate regulatory requirements ...
Validation Associate
Rocky Mount, NC · On-site
$46/hr
Writing and execution/coordination of validation protocol testing. * Compile and report on relevant validation data and generate summary reports to document the results of the validation studies.
Validation Associate
Rocky Mount, NC · On-site
$46/hr
Writing and execution/coordination of validation protocol testing. * Compile and report on relevant validation data and generate summary reports to document the results of the validation studies.
Validation Specialist
Allentown, PA · On-site
Experience coordinating validation activities with equipment vendors, contractors, Quality, Engineering, and Operations. * Client-focused, collaborative approach with the ability to communicate ...
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Validation Specialist
Allentown, PA · On-site
Experience coordinating validation activities with equipment vendors, contractors, Quality, Engineering, and Operations. * Client-focused, collaborative approach with the ability to communicate ...
Experience coordinating validation activities with equipment vendors, contractors, Quality, Engineering, and Operations. * Client-focused, collaborative approach with the ability to communicate ...
Experience coordinating validation activities with equipment vendors, contractors, Quality, Engineering, and Operations. * Client-focused, collaborative approach with the ability to communicate ...
Validation Engineer
Caguas, PR · On-site
Hands-on role focused on protocol execution, technical troubleshooting, and direct coordination ... Support the full Validation Life Cycle: planning, URS/FRS, risk assessment (FMEA), RTM, execution ...
Validation Engineer
Caguas, PR · On-site
Hands-on role focused on protocol execution, technical troubleshooting, and direct coordination ... Support the full Validation Life Cycle: planning, URS/FRS, risk assessment (FMEA), RTM, execution ...
Validation Specialist
Allentown, PA · On-site
Experience coordinating validation activities with equipment vendors, contractors, Quality, Engineering, and Operations. * Client-focused, collaborative approach with the ability to communicate ...
Validation Specialist
Allentown, PA · On-site
Experience coordinating validation activities with equipment vendors, contractors, Quality, Engineering, and Operations. * Client-focused, collaborative approach with the ability to communicate ...
Validation Engineer
Valley Falls, KS · On-site
Coordinates and communicates all testing with affected functional groups and evaluates test results. Executes equipment, facility, utility and computer system, Automated Process Control validation ...
Validation Engineer
Valley Falls, KS · On-site
Coordinates and communicates all testing with affected functional groups and evaluates test results. Executes equipment, facility, utility and computer system, Automated Process Control validation ...
Validation Specialist
Aibonito, PR · On-site
Strong technical writing, documentation, organizational, and project coordination skills. * Ability to work collaboratively with cross‑functional teams and manage multiple validation activities ...
Validation Specialist
Aibonito, PR · On-site
Strong technical writing, documentation, organizational, and project coordination skills. * Ability to work collaboratively with cross‑functional teams and manage multiple validation activities ...
Ensuring the timely development, execution, and coordination of all validation activities pertaining to facility, equipment, and process in compliance with Quality System requirements, site ...
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Ensuring the timely development, execution, and coordination of all validation activities pertaining to facility, equipment, and process in compliance with Quality System requirements, site ...
Validation Lead
Brooklyn Park, MN · On-site
This role coordinates, supports and assists all aspects of a computerized systems validation project from original concept through the final implementation. Develops project budgets and manages ...
Validation Lead
Brooklyn Park, MN · On-site
This role coordinates, supports and assists all aspects of a computerized systems validation project from original concept through the final implementation. Develops project budgets and manages ...
Validation Engineer
Petersburg, VA · On-site
$90K - $115K/yr
Participate in project planning, scheduling, and resource coordination to ensure validation deliverables are completed on time. Equipment, Facilities & Utility Qualification Support qualification and ...
Validation Engineer
Petersburg, VA · On-site
$90K - $115K/yr
Participate in project planning, scheduling, and resource coordination to ensure validation deliverables are completed on time. Equipment, Facilities & Utility Qualification Support qualification and ...
Validation Specialist
Aibonito, PR · On-site
Strong technical writing, documentation, organizational, and project coordination skills. * Ability to work collaboratively with cross-functional teams and manage multiple validation activities ...
Validation Specialist
Aibonito, PR · On-site
Strong technical writing, documentation, organizational, and project coordination skills. * Ability to work collaboratively with cross-functional teams and manage multiple validation activities ...
Engineer, Validation
Boca Raton, FL · On-site
Manager, schedule, coordinate, and execute assigned qualification or validation activities to ensuretimely completion of the validation plan in coordination with the system owner.
Engineer, Validation
Boca Raton, FL · On-site
Manager, schedule, coordinate, and execute assigned qualification or validation activities to ensuretimely completion of the validation plan in coordination with the system owner.
Validation Coordinator information
See salary details
$11.06 - $14.10
4% of jobs
$14.10 - $17.13
15% of jobs
$17.72 is the 25th percentile. Wages below this are outliers.
$17.13 - $20.17
32% of jobs
$20.17 - $23.21
20% of jobs
$24.50 is the 75th percentile. Wages above this are outliers.
$23.21 - $26.25
11% of jobs
$26.25 - $29.28
7% of jobs
$29.28 - $32.32
4% of jobs
$32.32 - $35.36
4% of jobs
$35.36 - $38.40
2% of jobs
$38.40 - $41.43
1% of jobs
$41.43 - $44.47
0% of jobs
$11
$23
$44
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Validation Specialist (Cleaning-In-Place)
Juana Diaz, PR • On-site
Full-time
Re-posted 24 days ago
Key responsibilities
Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.
Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.
Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.
Job description
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Specialist - CIP
Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.
Key Responsibilities:
Commissioning & Qualification Execution:
- Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.
- Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.
- Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).
- Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.
Documentation & Compliance:
- Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.
- Ensure traceability from design specifications through executed testing.
- Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.
- Prepare summary reports for Quality Assurance approval.
Cross-functional Collaboration:
- Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.
- Support operations during process validation batches and cleaning validation campaigns.
- Provide training and technical guidance to CQV engineers and contractors executing test protocols.
Qualifications:
- Bachelor's degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).
- Minimum 7�10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.
- Experience in generating and executing documentation for CQV activities.
- Strong knowledge of cleaning validation, sterilization principles, and automation integration.
- Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.
- Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.
- Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.
- Experience executing or overseeing FAT/SAT, IOQ, PQ activities.
- Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Available to work extended hours, possibility of weekends and holidays.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.