Raleigh, NC · On-site
... Engineering, QC, and Regulatory teams to ensure all validation activities meet GMP, FDA, and internal quality standards. Key Responsibilities * Lead end-to-end validation activities for pharma ...
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Raleigh, NC · On-site
... Engineering, QC, and Regulatory teams to ensure all validation activities meet GMP, FDA, and internal quality standards. Key Responsibilities * Lead end-to-end validation activities for pharma ...
Raleigh, NC · On-site
$70 - $80/hr
Process Engineer -- Upstream / Downstream / Clean Utilities (Consultant) -- Contract Engagement ... Join Us Salary Range: $70 - $80 / hourly range is an estimate of pay for project-based employment.
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Raleigh, NC · On-site
$70 - $80/hr
Process Engineer -- Upstream / Downstream / Clean Utilities (Consultant) -- Contract Engagement ... Join Us Salary Range: $70 - $80 / hourly range is an estimate of pay for project-based employment.
Raleigh, NC · On-site +1
It provides process engineering, process design, and commissioning - qualification - validation ... Knowledge of the local pharma market * Ability to lead and or assist in project execution Education ...
Raleigh, NC · On-site +1
It provides process engineering, process design, and commissioning - qualification - validation ... Knowledge of the local pharma market * Ability to lead and or assist in project execution Education ...
Holly Springs, NC · On-site
Coordinate with engineering, automation, validation, quality, and operations teams. * Support ... Required Experience * 5+ years of CQV/startup experience in pharma, biotech, or life sciences.
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Holly Springs, NC · On-site
Coordinate with engineering, automation, validation, quality, and operations teams. * Support ... Required Experience * 5+ years of CQV/startup experience in pharma, biotech, or life sciences.
Holly Springs, NC · On-site
CQV Engineer Location: Holly Springs, NC Duration: Long-Term Contract Summary: We are hiring ... Required Skills * 5+ years of CQV/startup/validation experience in pharma, biotech, or life ...
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Holly Springs, NC · On-site
CQV Engineer Location: Holly Springs, NC Duration: Long-Term Contract Summary: We are hiring ... Required Skills * 5+ years of CQV/startup/validation experience in pharma, biotech, or life ...
We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors ... validation programs. Qualifications * Bachelor's degree in Engineering, Chemistry, Life Sciences ...
We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors ... validation programs. Qualifications * Bachelor's degree in Engineering, Chemistry, Life Sciences ...
We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors ... validation programs. Qualifications * Bachelor's degree in Engineering, Chemistry, Life Sciences ...
We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors ... validation programs. Qualifications * Bachelor's degree in Engineering, Chemistry, Life Sciences ...
Fuquay Varina, NC · On-site
$40 - $45/hr
Fuquay-Varina, NC Salary: $40.00 USD Hourly - $45.00 USD Hourly Description: Location: Fuquay ... Provide technical support to marketing, product engineering, manufacturing, quality, and supply ...
Fuquay Varina, NC · On-site
$40 - $45/hr
Fuquay-Varina, NC Salary: $40.00 USD Hourly - $45.00 USD Hourly Description: Location: Fuquay ... Provide technical support to marketing, product engineering, manufacturing, quality, and supply ...
Automation Engineer - Aseptic Filling (Pharma/Biotech) Location: Raleigh, North Carolina (Onsite ... Collaborate with QA, Manufacturing, and Validation teams Requirements: * Experience in aseptic ...
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Automation Engineer - Aseptic Filling (Pharma/Biotech) Location: Raleigh, North Carolina (Onsite ... Collaborate with QA, Manufacturing, and Validation teams Requirements: * Experience in aseptic ...
Raleigh, NC · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
Raleigh, NC · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
Raleigh, NC · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
Raleigh, NC · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
Raleigh, NC · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
Raleigh, NC · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
Title: Network Engineer in Pharma/Biotech Domain Location: Raleigh, NC Duration: 6 months ... Support IQ/OQ/PQ validation protocols provide network diagrams, configuration baselines, and change ...
Title: Network Engineer in Pharma/Biotech Domain Location: Raleigh, NC Duration: 6 months ... Support IQ/OQ/PQ validation protocols provide network diagrams, configuration baselines, and change ...
Cary, NC · On-site
Desktop Support Engineer (Biotech/Pharma - GxP Environment) Location: Onsite - Cary, NC & San ... Work closely with IT, QA, and Compliance teams to support validated systems and GxP applications
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Cary, NC · On-site
Desktop Support Engineer (Biotech/Pharma - GxP Environment) Location: Onsite - Cary, NC & San ... Work closely with IT, QA, and Compliance teams to support validated systems and GxP applications
Raleigh, NC · On-site
Pharma experience isn't required -- we'll teach you the industry. What you'll do * Lead physical ... Hand off a fully working, fully documented system to our Validation Team. * Travel ~70% across the ...
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Raleigh, NC · On-site
Pharma experience isn't required -- we'll teach you the industry. What you'll do * Lead physical ... Hand off a fully working, fully documented system to our Validation Team. * Travel ~70% across the ...
Raleigh, NC · On-site
Pharma experience isn't required - we'll teach you the industry. What you'll do * Lead physical ... Hand off a fully working, fully documented system to our Validation Team. * Travel ~70% across the ...
Raleigh, NC · On-site
Pharma experience isn't required - we'll teach you the industry. What you'll do * Lead physical ... Hand off a fully working, fully documented system to our Validation Team. * Travel ~70% across the ...
Raleigh, NC · On-site +1
Company Description It all started when engineer Fred Luddy wrote code that automated a tedious ... technical validation on strategic accounts with an established senior relationship and largely ...
Raleigh, NC · On-site +1
Company Description It all started when engineer Fred Luddy wrote code that automated a tedious ... technical validation on strategic accounts with an established senior relationship and largely ...
Company Description It all started when engineer Fred Luddy wrote code that automated a tedious ... technical validation on strategic accounts with an established senior relationship and largely ...
Company Description It all started when engineer Fred Luddy wrote code that automated a tedious ... technical validation on strategic accounts with an established senior relationship and largely ...
Company Description It all started when engineer Fred Luddy wrote code that automated a tedious ... technical validation on strategic accounts with an established senior relationship and largely ...
Company Description It all started when engineer Fred Luddy wrote code that automated a tedious ... technical validation on strategic accounts with an established senior relationship and largely ...
... pharma/biotech environments, ensuring compliance with GMP and regulatory standards. Key ... Lead commissioning, validation (FAT/SAT, IQ/OQ/PQ), and documentation * Integrate DCS with SCADA ...
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... pharma/biotech environments, ensuring compliance with GMP and regulatory standards. Key ... Lead commissioning, validation (FAT/SAT, IQ/OQ/PQ), and documentation * Integrate DCS with SCADA ...
$21.97 - $26.87
2% of jobs
$26.87 - $31.78
6% of jobs
$31.78 - $36.69
13% of jobs
$38.22 is the 25th percentile. Wages below this are outliers.
$36.69 - $41.59
13% of jobs
$41.59 - $46.50
11% of jobs
The median wage is $48.95 / hr.
$46.50 - $51.41
12% of jobs
$51.41 - $56.31
9% of jobs
$60.10 is the 75th percentile. Wages above this are outliers.
$56.31 - $61.22
13% of jobs
$61.22 - $66.13
13% of jobs
$66.13 - $71.04
6% of jobs
$71.04 - $75.94
3% of jobs
$21
$50
$75
We are seeking an experienced Validation Lead to support validation activities within a pharmaceutical manufacturing environment. The role will be responsible for leading equipment qualification, process validation, cleaning validation, computerized system validation support, and compliance documentation. The Validation Lead will work closely with Manufacturing, Quality Assurance, Engineering, QC, and Regulatory teams to ensure all validation activities meet GMP, FDA, and internal quality standards.
Key ResponsibilitiesLead end-to-end validation activities for pharma manufacturing equipment, utilities, facilities, and processes.
Prepare, review, and approve validation documents including DQ, IQ, OQ, PQ, protocols, reports, SOPs, risk assessments, and validation plans.
Manage and execute process validation, cleaning validation, equipment qualification, and requalification activities.
Ensure validation deliverables comply with cGMP, FDA, 21 CFR Part 11, GAMP 5, and company quality procedures.
Coordinate with cross-functional teams including QA, Manufacturing, Engineering, QC, Automation, and Regulatory Affairs.
Review deviations, change controls, CAPAs, and investigations related to validation activities.
Lead validation project planning, scheduling, resource coordination, and execution tracking.
Support internal audits, client audits, and regulatory inspections by providing validation documentation and technical responses.
Ensure proper maintenance of validation lifecycle documentation and traceability.
Mentor junior validation engineers and provide technical guidance to the validation team.
Strong experience in pharmaceutical manufacturing validation.
Hands-on knowledge of equipment qualification, process validation, cleaning validation, and utility validation.
Good understanding of cGMP, FDA guidelines, 21 CFR Part 11, GAMP 5, ALCOA+, and data integrity principles.
Experience preparing and reviewing IQ/OQ/PQ protocols and reports.
Ability to manage deviations, CAPA, change controls, and validation risk assessments.
Strong documentation, technical writing, and review skills.
Experience working with QA, Manufacturing, Engineering, QC, and Automation teams.
Good project coordination and leadership skills.
Familiarity with pharma systems such as MES, LIMS, TrackWise, SAP, Veeva, SCADA, or PLC-based systems is preferred.
Excellent communication, problem-solving, and team management skills.
Sourced by ZipRecruiter
51 - 200 Employees
Iselin, NJ, US
2018
