Validation Engineer
Durham, NC · On-site
Experience in a sterile or pharmaceutical environment is required but will consider other FDA -- cGMP experience and medical device or combination product production Performed validation of Quality ...
Durham, NC · On-site
Experience in a sterile or pharmaceutical environment is required but will consider other FDA -- cGMP experience and medical device or combination product production Performed validation of Quality ...
Durham, NC · On-site
Experience in a sterile or pharmaceutical environment is required but will consider other FDA -- cGMP experience and medical device or combination product production Performed validation of Quality ...
Support pharmaceutical capital projects involving: * Active pharmaceutical ingredient (API ... Develop, review, and maintain validation and qualification documentation within electronic ...
Support pharmaceutical capital projects involving: * Active pharmaceutical ingredient (API ... Develop, review, and maintain validation and qualification documentation within electronic ...
Validation test scripts * Traceability matrices * Summary reports * Support startup and ... pharmaceutical engineering experience within GMP-regulated environments. * Strong knowledge of ...
Quick apply
Validation test scripts * Traceability matrices * Summary reports * Support startup and ... pharmaceutical engineering experience within GMP-regulated environments. * Strong knowledge of ...
We are seeking an experienced Senior CQV Project Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives.
Quick apply
We are seeking an experienced Senior CQV Project Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives.
We are seeking an experienced Senior CQV Project Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives.
We are seeking an experienced Senior CQV Project Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives.
Validation test scripts * Traceability matrices * Summary reports * Support startup and ... pharmaceutical engineering experience within GMP-regulated environments. * Strong knowledge of ...
Validation test scripts * Traceability matrices * Summary reports * Support startup and ... pharmaceutical engineering experience within GMP-regulated environments. * Strong knowledge of ...
Durham, NC · On-site
$120K - $140K/yr
Minimum 7+ years of validation, commissioning, qualification, or quality engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. * Demonstrated ...
Quick apply
Durham, NC · On-site
$120K - $140K/yr
Minimum 7+ years of validation, commissioning, qualification, or quality engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. * Demonstrated ...
Durham, NC · On-site
Minimum 7+ years of validation, commissioning, qualification, or quality engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. Demonstrated ...
Durham, NC · On-site
Minimum 7+ years of validation, commissioning, qualification, or quality engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. Demonstrated ...
Chapel Hill, NC · On-site
Knowledge of the pharmaceutical validation process or experience with CIP/SIP systems is desired. Expertise of our most successful Process Engineer II: * Bachelor's degree in engineering (Mechanical ...
Chapel Hill, NC · On-site
Knowledge of the pharmaceutical validation process or experience with CIP/SIP systems is desired. Expertise of our most successful Process Engineer II: * Bachelor's degree in engineering (Mechanical ...
Minimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required * Experience in writing & executing validation ...
Minimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required * Experience in writing & executing validation ...
Durham, NC · On-site
Minimum 7+ years of validation, commissioning, qualification, or quality engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. * Demonstrated ...
Durham, NC · On-site
Minimum 7+ years of validation, commissioning, qualification, or quality engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. * Demonstrated ...
Durham, NC · On-site
$80 - $100/hr
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling ... Support validation activities associated with changes to existing & new systems as assigned.
Durham, NC · On-site
$80 - $100/hr
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling ... Support validation activities associated with changes to existing & new systems as assigned.
Raleigh, NC · On-site
$72K - $80K/yr
... Pharmaceutical facilities - Utilities - Equipment 3. Project & Team Management - Plan and coordinate work - Direct small teams in document development and/or execution Qualifications and Experience ...
Raleigh, NC · On-site
$72K - $80K/yr
... Pharmaceutical facilities - Utilities - Equipment 3. Project & Team Management - Plan and coordinate work - Direct small teams in document development and/or execution Qualifications and Experience ...
Raleigh, NC · On-site
$72K - $80K/yr
... Pharmaceutical facilities - Utilities - Equipment 3. Project & Team Management - Plan and coordinate work - Direct small teams in document development and/or execution Qualifications and Experience ...
Quick apply
Raleigh, NC · On-site
$72K - $80K/yr
... Pharmaceutical facilities - Utilities - Equipment 3. Project & Team Management - Plan and coordinate work - Direct small teams in document development and/or execution Qualifications and Experience ...
... pharmaceutical, or biotechnology preferred). * Strong knowledge of validation principles, including IQ/OQ/PQ, with hands-on experience in software, hardware, and manufacturing environments. * Solid ...
... pharmaceutical, or biotechnology preferred). * Strong knowledge of validation principles, including IQ/OQ/PQ, with hands-on experience in software, hardware, and manufacturing environments. * Solid ...
Durham, NC · On-site
Bachelor's or Master's degree in Engineering (Mechanical, Chemical, or related discipline) * 5-8+ years of experience in cleaning validation and CQV within pharmaceutical, biopharmaceutical, or CDMO ...
Quick apply
Durham, NC · On-site
Bachelor's or Master's degree in Engineering (Mechanical, Chemical, or related discipline) * 5-8+ years of experience in cleaning validation and CQV within pharmaceutical, biopharmaceutical, or CDMO ...
... pharmaceutical, or biotechnology preferred). * Strong knowledge of validation principles, including IQ/OQ/PQ, with hands-on experience in software, hardware, and manufacturing environments. * Solid ...
... pharmaceutical, or biotechnology preferred). * Strong knowledge of validation principles, including IQ/OQ/PQ, with hands-on experience in software, hardware, and manufacturing environments. * Solid ...
Raleigh, NC · On-site
$125 - $150/hr
... pharmaceutical, or biotechnology preferred). * Strong knowledge of validation principles, including IQ/OQ/PQ, with hands-on experience in software, hardware, and manufacturing environments. * Solid ...
Raleigh, NC · On-site
$125 - $150/hr
... pharmaceutical, or biotechnology preferred). * Strong knowledge of validation principles, including IQ/OQ/PQ, with hands-on experience in software, hardware, and manufacturing environments. * Solid ...
Durham, NC · On-site
Bachelor's or Master's degree in Engineering (Mechanical, Chemical, or related discipline) * 5-8+ years of experience in cleaning validation and CQV within pharmaceutical, biopharmaceutical, or CDMO ...
Durham, NC · On-site
Bachelor's or Master's degree in Engineering (Mechanical, Chemical, or related discipline) * 5-8+ years of experience in cleaning validation and CQV within pharmaceutical, biopharmaceutical, or CDMO ...
... pharmaceutical, or biotechnology preferred). * Strong knowledge of validation principles, including IQ/OQ/PQ, with hands-on experience in software, hardware, and manufacturing environments. * Solid ...
... pharmaceutical, or biotechnology preferred). * Strong knowledge of validation principles, including IQ/OQ/PQ, with hands-on experience in software, hardware, and manufacturing environments. * Solid ...
$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
A Pharmaceutical Validation job involves ensuring that systems, equipment, and processes in the pharmaceutical industry meet regulatory and quality standards. Professionals in this role develop protocols, conduct testing, and document validation activities to ensure compliance with regulations like FDA, EU GMP, and ISO standards. They work with manufacturing processes, laboratory instruments, and software to verify that products are consistently produced and controlled according to required quality standards. This role is critical in maintaining drug safety, efficacy, and regulatory approval.
One of the main challenges in Pharmaceutical Validation is staying updated with constantly evolving regulatory requirements and ensuring that all validation activities meet stringent compliance standards. Professionals often manage multiple concurrent projects, which requires effective prioritization, organization, and close coordination with cross-functional teams such as quality assurance, manufacturing, and engineering. Thorough documentation and meticulous attention to detail are essential, as even minor oversights can lead to compliance issues. However, overcoming these challenges provides valuable problem-solving experience and opportunities for advancement within quality assurance, regulatory affairs, or project management.
To thrive in Pharmaceutical Validation, you need a strong background in pharmaceutical sciences or engineering, familiarity with regulatory guidelines (such as FDA, GMP, and ICH), and hands-on experience in validation protocols. Proficiency with validation lifecycle documentation tools, quality management systems (QMS), and specialized software like TrackWise or ValGenesis is essential. Attention to detail, analytical thinking, and excellent collaboration and communication skills are highly valued in this role. These competencies ensure that pharmaceutical processes, equipment, and systems meet strict quality standards, supporting product safety and regulatory compliance.
The most popular types of Pharmaceutical Validation jobs in Raleigh, NC are:
For Pharmaceutical Validation jobs in Raleigh, NC, the most frequently searched job titles are:
The top searched job categories for Pharmaceutical Validation jobs in Raleigh, NC are:
Cities near Raleigh, NC with the most Pharmaceutical Validation job openings:

IRI believes in commitment, Integrity and strategic workforce solutions.
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.
Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.
Experience in a sterile or pharmaceutical environment is required but will consider other FDA -- cGMP experience and medical device or combination product production
Performed validation of Quality Control laboratories instruments (with and without computer systems) according to the site's applicable validation SOPs.
Authors validation deliverables as required.
Ensure that the system is installed and configured in a 21 CFR Part 11/Annex 11 compliant manner.
Provide validation expertise and support to the Quality Control laboratories.
At least 4 years' experience validating equipment
At least 2 years' experience validating laboratory instruments with computer systems
Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in Quality Control laboratories.
Authors cGMP risk assessments, user requirements and function specifications, validation plans, protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation deliverables as required by the site validation SOPs. Previous experience with validation of laboratory instrument systems preferred.
Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.
Assist the system owner with evaluating recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and preventive maintenance plans.
Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument.
Previous experience with PR/CAPA systems preferred.
Ensures lab instrument's adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines. Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence. For systems found unable to fully comply, formulate workarounds/strategies to mitigate the gaps.
Initiates and leads risk assessment, gap analysis, and deviation management associated with validation of lab instruments.
Support and assist teammates wherever possible.
Perform other related duties as assigned or required.
Quality Laboratories Subject Matter Experts for the respective instruments
Quality Laboratories System Owners for the respective instruments
Quality Laboratories System Super Users (if applicable) for the respective instruments
Instrumentation Team (if applicable) for instrument calibration
Regards,
Indu
Clinical Recruiter
732-844-8725
indu @irionline.com
Sourced by ZipRecruiter
Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.
Recruiting and staffing services
51 - 200 Employees
Edison, NJ, US
1996