Computerized system validation jobs

Lab IT Engineer

ALTEN Technology USA · Posted Nov 13, 2026

Open

Cambridge, Massachusetts, United States
On-site
Full-time · Mid
$90K–$110K per year

Lab IT Engineer

ALTEN Technology USA · Posted Nov 13, 2026

Open

Cambridge, Massachusetts, United States
On-site
Full-time · Mid
$90K–$110K per year

CSV Lead

JC Automation Corp · Posted Nov 13, 2026

Open

Manati, Puerto Rico, United States
Senior
4+ years

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Lead the execution of IT Computerized Systems Validation and Data Integrity programs for a pharmaceutical manufacturing facility.

Responsibilities

Assures IT Compliance commitments are planned, monitored and completed
Keeps abreast of regulatory developments applicable to IT Systems
Serves as the Site IT Subject Matter Expert for IT Compliance issues
Ensures the development, implementation, execution and sustainability of an efficient Software/Computer System Validation program
Ensures Periodic Reviews for computerized systems are completed as per plan

Requirements

Bachelor’s Degree in Science (Computer Systems or Engineering preferred)

Skills

computerized system validation data integrity 21 CFR Part 11 cGMP FDA regulations project management

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Quality Assurance Specialist with focus on Production support

Getinge · Posted Nov 12, 2026

Open

Solna, Stockholm County, Sweden
On-site
3–5 years

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Support manufacturing quality processes, perform audits, manage CAPA, and validate software applications used in manufacturing and quality management.

Compensation

We offer a competitive compensation and benefits package, including wellness allowances, generous family benefits and joint company activities.

Responsibilities

Act as independent reviewer of production process changes, including process validation and production process risk assessments
Support non-conformance handling in manufacturing and coordinate product holds for high-risk non-conforming products
Support the organization on quality issues and improve procedures in the management system, specifically for manufacturing controls
Support implementation, validation and management of software applications used in manufacturing and within the quality management system
Perform internal audits and track non-conformances to closure, and support preparation of external audits and the CAPA process

Requirements

M.Sc. or B.Sc. in science or engineering

Skills

quality and compliance manufacturing of medical devices ISO 13485

Quality Manager

Cadence Inc · Posted Nov 12, 2026

Open

Cranberry Township, Pennsylvania, United States
Full-time · Manager
5+ years

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Lead the Quality function at a medical device contract manufacturing site, overseeing compliance, continuous improvement, and team development.

Responsibilities

Lead, develop, and mentor the site Quality team
Ensure compliance with FDA regulations, ISO standards, and customer requirements
Maintain and improve the site’s Quality Management System (QMS)
Provide oversight for validation activities (IQ/OQ/PQ, process validation, equipment qualification, computerized system validation)
Prepare for and support customer audits, regulatory inspections, and third‑party audits

Requirements

Bachelor's degree in Engineering, Quality, or a related technical discipline
Nice to have: pharmaceutical manufacturing experience

Skills

FDA regulations ISO 13485 FDA 21 CFR Part 210 FDA 21 CFR Part 211 FDA 21 CFR Part 11 validation and qualification requirements

Senior CSV Specialist – Data Integrity

Inteldot · Posted Nov 11, 2026

Open

Manati, Manatí, Puerto Rico
Senior

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Senior Computerized System Validation (CSV) Specialist to provide technical leadership and compliance support for computerized systems within a regulated pharmaceutical manufacturing environment.

Responsibilities

Lead and execute Computerized System Validation (CSV) activities for computerized systems supporting manufacturing, sterile and non-sterile operations, laboratories, packaging, inspection, utilities, and facilities.
Develop, review, and execute computer system validation strategies, validation plans, protocols, test scripts, and supporting documentation.
Establish and maintain an effective CSV program aligned with applicable regulatory requirements, corporate standards, and site quality procedures.
Serve as the technical Subject Matter Expert (SME) for IT Compliance, Computerized System Validation, Data Integrity, and electronic records requirements.
Ensure computerized systems are appropriately validated and compliant before being released for their intended use.

Requirements

Bachelor’s degree in science, Computer Science, Engineering, Information Systems
Nice to have: MES
Nice to have: eBR
Nice to have: LIMS
Nice to have: automation platforms

Skills

Computerized System Validation (CSV)Data Integrity

CSV Specialist – MES/EBR Validation

Inteldot · Posted Nov 11, 2026

Open

Manati, United States

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Provide validation and documentation support for Manufacturing Execution Systems (MES) and Electronic Batch Records (eBRs) in a regulated pharmaceutical manufacturing environment.

Responsibilities

Develop, review, update, execute, and maintain computerized system validation documentation in accordance with GMP regulations and data integrity principles.
Support validation lifecycle documentation including URS, Functional Specifications, Design Specifications, Configuration Specifications, Risk Assessments, and Traceability Matrices.
Develop and execute IQ/OQ testing protocols and document validation results.
Coordinate activities with cross‑functional technical and business teams.
Prepare and review validation reports and summary reports.

Requirements

Bachelor’s degree in engineering, Computer Science, Information Technology, Life Sciences, Chemistry, or a related technical discipline
Nice to have: Syncade Enterprise MES (EMES)
Nice to have: Electronic batch record implementation
Nice to have: CSV risk assessments
Nice to have: Data Integrity Assessments

Skills

Computerized System Validation (CSV)Manufacturing Execution Systems (MES)Electronic Batch Records (eBRs)FDA cGMP regulations Good Documentation Practices (GDP)Data Integrity principles URS Functional Specifications Design Specifications Configuration Specifications Risk Assessments Traceability Matrices IQ/OQ testing protocols Application Lifecycle Management (ALM) tools

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Senior Quality IT & Data Integrity Specialist

MSD · Posted Nov 10, 2026

Open

Dunboyne, Meath, Ireland
Hybrid
Full-time · Senior

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Senior Quality IT & Data Integrity Specialist supporting biologics manufacturing operations

Responsibilities

Provide quality oversight for Data Integrity and computerized systems across manufacturing and laboratory operations
Lead and support Data Integrity-related deviations, investigations, root cause analysis and corrective and preventive actions
Partner with system, process and data owners to ensure computerized systems meet business, quality and regulatory requirements
Review and approve computerized system validation documentation, system changes, deviations and associated quality records
Ensure computerized systems remain in a validated and compliant state throughout their lifecycle

Requirements

Degree in Computer Science, Engineering, Life Sciences, Quality or a related discipline
Nice to have: Biopharmaceutical Operations

Skills

Data Integrity Data Integrity investigations Deviations Quality investigations Computerized system validation

Director/Senior Director, Clinical Quality

Braveheart Bio · Posted Nov 6, 2026

Open

San Francisco, California, United States
Manager
$200K–$290K per year
10+ years

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Lead clinical quality strategy and oversight for Braveheart Bio’s late-stage clinical program.

Compensation

Base Salary Range: $200,000 - $290,000

Responsibilities

Lead clinical quality strategy aligned with global regulatory requirements
Establish fit-for-purpose quality practices that support late-stage development and inspection readiness
Serve as a trusted quality partner to clinical teams, proactively identifying, assessing, and mitigating risk
Drive continuous improvement to strengthen quality culture, streamline execution, and improve compliance effectiveness
Serve as the company’s GCP subject matter expert

Requirements

Bachelor's degree in life sciences, nursing, or related discipline
Nice to have: rare disease clinical development
Nice to have: cardiovascular clinical development
Nice to have: specialty-disease clinical development
Nice to have: regulatory submissions (NDA/BLA/MAA)

Skills

GCP quality experience risk-based quality principles global clinical development

Lab IT Engineer

Lab IT Engineer

Compensation

Responsibilities

Requirements

Skills

Benefits

CSV Lead

Responsibilities

Requirements

Skills

Quality Assurance Specialist with focus on Production support

Compensation

Responsibilities

Requirements

Skills

Quality Manager

Responsibilities

Requirements

Skills

Senior CSV Specialist – Data Integrity

Responsibilities

Requirements

Skills

CSV Specialist – MES/EBR Validation

Responsibilities

Requirements

Skills

Senior Quality IT & Data Integrity Specialist

Responsibilities

Requirements

Skills

Director/Senior Director, Clinical Quality

Compensation

Responsibilities

Requirements

Skills

Benefits

Benefits