Develops user requirements regarding Quality training systems and supports the generation/review/approval of computer system validation deliverables. * Contributes to the generation, review, and ...
Develops user requirements regarding Quality training systems and supports the generation/review/approval of computer system validation deliverables. * Contributes to the generation, review, and ...
Validation Engineer
Raleigh, NC · On-site
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
Validation Engineer
Raleigh, NC · On-site
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
Validation Engineer
Raleigh, NC · On-site
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
Validation Engineer
Raleigh, NC · On-site
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
Validation Engineer
Raleigh, NC · On-site
Support cleaning validation for manufacturing equipment including process vessels, CIP systems, autoclaves, and parts washers * Investigate deviations, discrepancies, and out-of-specification results ...
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Validation Engineer
Raleigh, NC · On-site
Support cleaning validation for manufacturing equipment including process vessels, CIP systems, autoclaves, and parts washers * Investigate deviations, discrepancies, and out-of-specification results ...
Manufacturing Digital Manager
Clayton, NC · On-site
Strong experience with data integrity principles, computer system validation (CSV), and GxP regulations * Demonstrated experience implementing or sustaining EBR/MES platforms. Preferred * Experience ...
Manufacturing Digital Manager
Clayton, NC · On-site
Strong experience with data integrity principles, computer system validation (CSV), and GxP regulations * Demonstrated experience implementing or sustaining EBR/MES platforms. Preferred * Experience ...
CSV Specialist II
Durham, NC · On-site
Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use.
CSV Specialist II
Durham, NC · On-site
Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all systems are in a qualified state suitable for the intended use.
Systems Manager, Digital Quality
Durham, NC · On-site
$120 - $150/hr
Lead/assist with vendor audits and oversee risk-based digital system validation assessments. We are Looking For: * Bachelor's degree or higher in IT, Computer Systems, Life Sciences, Engineering, or ...
Systems Manager, Digital Quality
Durham, NC · On-site
$120 - $150/hr
Lead/assist with vendor audits and oversee risk-based digital system validation assessments. We are Looking For: * Bachelor's degree or higher in IT, Computer Systems, Life Sciences, Engineering, or ...
Validation Engineer
Raleigh, NC · On-site
Validation Engineer Job Location: Raleigh - North Carolina Job Type: Contract * Manage lab servers ... Perform system provisioning installation configuration and upgrades * Support daily lab operations ...
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Validation Engineer
Raleigh, NC · On-site
Validation Engineer Job Location: Raleigh - North Carolina Job Type: Contract * Manage lab servers ... Perform system provisioning installation configuration and upgrades * Support daily lab operations ...
Lead/assist with vendor audits and oversee risk-based digital system validation assessments. We are Looking For: * Bachelor's degree or higher in IT, Computer Systems, Life Sciences, Engineering, or ...
Lead/assist with vendor audits and oversee risk-based digital system validation assessments. We are Looking For: * Bachelor's degree or higher in IT, Computer Systems, Life Sciences, Engineering, or ...
Validation Lead
Durham, NC · On-site
$126K - $234K/yr
Strong knowledge of quality systems applied statistics, and global regulatory requirements. * Demonstrated success managing complex cross-functional projects and authoring technical validation ...
Validation Lead
Durham, NC · On-site
$126K - $234K/yr
Strong knowledge of quality systems applied statistics, and global regulatory requirements. * Demonstrated success managing complex cross-functional projects and authoring technical validation ...
... computer science, or related field. * Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments. * Proven experience with equipment‑level PLC/HMI validation (OEM systems) and ...
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... computer science, or related field. * Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments. * Proven experience with equipment‑level PLC/HMI validation (OEM systems) and ...
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2
Durham, NC · On-site
$65K - $90K/yr
... computer science, or related field. * Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments. * Proven experience with equipment-level PLC/HMI validation (OEM systems) and ...
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2
Durham, NC · On-site
$65K - $90K/yr
... computer science, or related field. * Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments. * Proven experience with equipment-level PLC/HMI validation (OEM systems) and ...
Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required. * Experience with developing and ...
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Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required. * Experience with developing and ...
Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required. * Experience with developing and ...
Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required. * Experience with developing and ...
Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required. * Experience with developing and ...
Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required. * Experience with developing and ...
Division Quality Engineer I
Durham, NC · On-site
$69K - $89K/yr
Support the standardization of computer systems validation procedures, templates, and documentation practices across division manufacturing and laboratory facilities * Support implementation and ...
Division Quality Engineer I
Durham, NC · On-site
$69K - $89K/yr
Support the standardization of computer systems validation procedures, templates, and documentation practices across division manufacturing and laboratory facilities * Support implementation and ...
Data Validation Specialist
Raleigh, NC · On-site
$22.50/hr
Maintain data integrity by working within databases and systems. * Meet deadlines while handling ... Ability to work 100% on a computer without phone calls or extensive email exchanges. * Comfortable ...
Data Validation Specialist
Raleigh, NC · On-site
$22.50/hr
Maintain data integrity by working within databases and systems. * Meet deadlines while handling ... Ability to work 100% on a computer without phone calls or extensive email exchanges. * Comfortable ...
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD) * Willing and able to ...
Serves as a source of expertise in the group for validating new systems * Ensure compliance of ... Bachelor's Degree in Engineering, Computer Science, or applicable technical degree or proven ...
Serves as a source of expertise in the group for validating new systems * Ensure compliance of ... Bachelor's Degree in Engineering, Computer Science, or applicable technical degree or proven ...
Computer System Validation information
See Wake Forest, NC salary details
$9.07 - $14.96
2% of jobs
$14.96 - $20.84
9% of jobs
$20.84 - $26.73
1% of jobs
$26.73 - $32.61
4% of jobs
$36.19 is the 25th percentile. Wages below this are outliers.
$32.61 - $38.50
15% of jobs
$38.50 - $44.38
9% of jobs
The median wage is $49.29 / hr.
$44.38 - $50.27
13% of jobs
$54.96 is the 75th percentile. Wages above this are outliers.
$50.27 - $56.16
29% of jobs
$56.16 - $62.04
12% of jobs
$62.04 - $67.93
2% of jobs
$67.93 - $73.81
5% of jobs
$9
$46
$73
How much do computer system validation jobs pay per hour?
What are some typical challenges faced in computer system validation roles?
Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.
What is a computer system validation?
A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.
What are the key skills and qualifications needed to thrive in computer system validation, and why are they important?
To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.
Is computer system validation a good field?
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Full-time
Posted 11 days ago
Job description
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview:
The Senior Manager, Compliance and Training, will provide expertise in training design and execution for Beam and support overall training management. This role is specifically responsible for developing, implementing, and administering global training while supporting the application of Global Quality Policies & Standards, Change Controls, and Deviation/Corrective and Preventive Action review and administration.
The position is critical to Beam's support of 21 CFR 211.25, which requires that personnel have the necessary education, training, and experience for their roles, including training in GMPs related to their functions.
The Senior Manager, Compliance and Training will provide training, training system technical support and expertise in training processes, procedures, and operational activities to Quality Systems users globally which includes, but is not limited to, System Training Development, Metrics, Application of Global Quality Policies & Standards. This role will support key stakeholders in ensuring compliance with training for phase-appropriate GxPs, global HR/Legal/regulatory training, and applicable global policies.
This role works cross-functionally and serves as a liaison between the Global Quality System and Compliance team and Beam. The Senior Manager, Compliance and Training is a key contributor role and reports to the Senior Director, Quality Systems and Compliance. This position is expected to be on-site three days a week.
Primary Responsibilities:
- Develops, leads, and implements training initiatives that are aligned with business strategies.
- Design, develop and deliver instructional materials, both digital and physical, in an efficient, effective, appealing, engaging way.
- Manages the performance/effectiveness of quality system training programs.
- Work collaboratively on the GXP integrated digital landscape to support, resolve system technical issues and communicate best practices for electronic quality training systems.
- Assist in the refinement of system user training and support training delivery.
- Assist in improving and maintaining Beam's overall Quality Management System (QMS), including policies and procedures, while keeping them current with emerging and changing regulations.
- Develops user requirements regarding Quality training systems and supports the generation/review/approval of computer system validation deliverables.
- Contributes to the generation, review, and approval of computer system test scripts.
- Support site and function audit preparations with respect to system functionality.
- Support development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instruction creation or maintenance) governing management and usage of Quality Systems.
- Maintain system-related metrics and assist in analyzing training effectiveness based on those metrics.
- Ability to own appropriate and complete system Quality Events (Issues, Change Controls and CAPAs) to meet internal procedures and regulatory expectations.
- Provides quality assurance guidance in a professional and collaborative manner to stakeholders.
Qualifications:
- University degree in scientific discipline/Life Sciences or equivalent experience in the biotech or pharmaceutical industry.
- 10+ years of relevant experience in a GMP and GXP environment with at least 3 years of demonstrated experience with the development, maintenance, and training oversight required.
- General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry.
- Skilled in determining the state and needs of the learner and defining the end goal of instruction.
- Excellent interpersonal effectiveness, written/verbal communication, influencing, and negotiation skills.
- Ability to work independently.
- Excellent computer skills and advanced knowledge of Quality Systems. Direct experience with Quality Management Systems, Document Management Systems, Learning Management Systems, and Microsoft Office, including Word and Excel.
- Self-motivator with the ability to follow up on and complete multiple projects simultaneously.
- Formal or technical writing experience.
- Highly attentive to details and able to work well as part of a team.
- Demonstrates consistent judgment, quality, accuracy, speed, and creativity.
- Understands, selects, and uses appropriate risk management and root cause analysis tools.
- Takes initiative in making improvement suggestions to promote operational goals.
- Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
- Facilitates designing processes with Quality built in from the beginning.
- Identifies and uses good judgement to handle out-of-compliance situations.
- Good listening and communication skills.
- Positive approach.
The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
Beam Pay Range
$155,000-$190,000 USD
About Beam Therapeutics
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
501 - 1,000 Employees
Headquarters location
Cambridge, MA, US
Year founded
2017