Computerized system validation jobs

Senior QA Specialist - C&Q

Johnson & Johnson · Posted Nov 4, 2026

Open

Wilson, North Carolina, United States
On-site
Full-time · Senior
6+ years

Senior QA Specialist - C&Q

Johnson & Johnson · Posted Nov 4, 2026

Open

Wilson, North Carolina, United States
On-site
Full-time · Senior
6+ years

Supervisor Quality Control Lab Operations

Regeneron · Posted Nov 4, 2026

Open

Rensselaer, New York, United States
Full-time
$80K–$131K per year
5+ years

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Supervisor of Quality Control (QC) Lab Operations to support a highly automated drug substance manufacturing facility.

Compensation

$80,300.00 - $131,300.00

Responsibilities

Hire, onboard, and develop team; define individual development plans tied to technical and leadership competencies
Set goals, provide ongoing coaching and feedback, and conduct performance reviews; address performance gaps through documented coaching and improvement plans
Maintain training compliance for direct reports and a team skills matrix covering equipment qualification, CSV, LIMS and CDS integration, and GMP document authorship
Maintain the integrated portfolio of lab builds, technology implementations, and upgrades scope, schedule, resource loading, and cross-project dependencies
Review scoping and business cases developed by the team; recommend prioritization and funding requests to QC management

Requirements

BS/BA in Life Sciences, Chemistry, or Engineering discipline

Skills

lab build relocation fit-out technology implementation

Senior QA Specialist - C&Q

6084-Janssen Research & Development Legal Entity · Posted Nov 4, 2026

Open

Wilson, North Carolina, United States
Full-time · Senior
6+ years

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Senior QA Specialist responsible for ensuring compliance with regulatory requirements and company policies in a new Biotherapeutics Manufacturing facility.

Responsibilities

Represent Quality Assurance on qualification teams and provide QA oversight of C&Q and validation execution across the capital project lifecycle
Support development and maintenance of the site validation program, Validation Master Plan, and project C&Q and validation plans
Participate in risk assessments and perform QA review of system impact assessments
Review and approve commissioning and qualification documentation
Ensure Good Documentation Practice and data integrity of vendor, EPCM and CQV contractor documentation

Requirements

Bachelor's degree in a scientific or engineering discipline
Master's degree in a scientific or engineering discipline
Nice to have: Subject Matter Expert in C&Q for regulated industries
Nice to have: Experience supporting greenfield or start-up sterile manufacturing facility
Nice to have: Hands-on QA experience with isolator filling lines and automated systems

Skills

Good Manufacturing Practices C&Q lifecycle Validation lifecycle (URS, CARA, FAT, SAT, IQ, OQ, PQ)

Senior Manufacturing Systems Expert

Novartis · Posted Nov 4, 2026

Open

Kundl, Tyrol, Austria
Hybrid
Full-time · Senior
€66K–€113K per year
3–5 years

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Provide technical expertise and ownership for the implementation of Manufacturing Execution System (MES) and electronic Batch Records (eBR) for one manufacturing line.

Compensation

€66,918.00 - €112,600.00

Responsibilities

Lead and support MES/eBR implementation across requirements, design, configuration/development, testing, qualification and rollout.
Translate manufacturing process and user requirements into robust MES/eBR functional and technical solutions.
Design, configure and maintain electronic batch records (eBRs) in accordance with manufacturing, quality, regulatory and business requirements.
Ensure harmonization and reuse of existing MES standards, templates and solutions, while addressing RPP5-specific manufacturing requirements.
Define, coordinate and support interfaces between MES and connected manufacturing/enterprise systems, such as SAP, automation/process control systems and other relevant production systems.

Requirements

Bachelor's or Master's degree in IT, Engineering, Automation, Manufacturing Technology or a comparable technical discipline, or equivalent technical education combined with relevant professional experience.
Nice to have: PAS-X
Nice to have: pharmaceutical MES/eBR platform
Nice to have: SAP integration
Nice to have: automation/process control systems (PLC/PCS)

Staff Validation Engineer

Thermo Fisher Scientific · Posted Oct 30, 2026

Open

Greenville, North Carolina, United States
On-site
Full-time · Staff
6+ years

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As a Staff Validation Engineer, you'll lead validation activities for critical systems, equipment, and processes that enable the development and manufacturing of therapies.

Responsibilities

Lead validation activities for critical systems, equipment, and processes
Develop and implement comprehensive validation strategies aligned with regulatory requirements and corporate standards
Collaborate with cross-functional teams to ensure successful qualification of facilities, utilities, manufacturing equipment, and computerized systems
Maintain compliance and drive continuous improvement
Serve as a technical subject matter expert during audits and investigations

Requirements

Advanced Degree plus 6 years of experience
Bachelor's Degree plus 8 years of experience
Engineering
Science
Biotechnology

Skills

cGMP regulations GAMP 5 21 CFR Part 11 validation lifecycle documentation risk assessments

Senior QA Specialist - C&Q

Senior QA Specialist - C&Q

Responsibilities

Requirements

Skills

Supervisor Quality Control Lab Operations

Compensation

Responsibilities

Requirements

Skills

Senior QA Specialist - C&Q

Responsibilities

Requirements

Skills

Senior Manufacturing Systems Expert

Compensation

Responsibilities

Requirements

Staff Validation Engineer

Responsibilities

Requirements

Skills

Benefits

Skills

Benefits