About the role

Aplyr's Quick Take

This role is focused on validating software and processes in a regulated environment, ensuring everything meets compliance and quality standards. You'll lead validation efforts, conduct risk assessments, and support audits, primarily working as an individual contributor rather than in a management capacity.

Good fit

Ideal candidates have at least 3 years of experience in quality engineering or validation within regulated industries. A background in engineering or life sciences and a hands-on approach to problem-solving will help you thrive here.

Worth noting

The role involves significant interaction with audits and inspections, which may be a red flag for those who prefer less oversight. However, it offers a chance to work on diverse validation projects, including software implementations and cloud applications.

Role Summary

The Software and Process Validation engineer is responsible for ensuring that computerized systems, manufacturing processes, equipment, utilities, facilities, and associated quality systems consistently perform as intended and comply with regulatory, quality, and business requirements. This role supports the full validation lifecycle, including planning, risk assessment, qualification, testing, documentation, change management, and maintenance of the validated state.

Key Responsibilities

Lead software validation for new systems and changes, including requirements, risk assessments, testing, traceability, deviations, reports, integrations, and data migrations.
Support audits, inspections, and quality investigations
Perform validation risk assessment utilizing the appropriate risk-validation and CSA principles
Evaluate data integrity, access controls, audit trails, electronic records and signatures, security, backup and recovery, and continued validated-state requirements.
Support process and equipment validation, including IQ/OQ/PQ, PPQ, cleaning, utilities, facilities, technology transfer, and new product introduction.
Apply change control, CAPA, deviation, document-control, and risk-management requirements; monitor milestones, escalate risks, and support audits and inspections.
Lead validation of GxP computerized systems.
Develop and execute validation plans.
Create and review: URS, risk assessments; traceability matrices; test scripts and validation reports.
Assess data integrity controls, audit trails, electronic records, and electronic signatures.
Support software implementations, upgrades, integrations, cloud applications, and system changes.

Required Qualifications

Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, Quality, or a related technical field.
At least 3 years of validation, quality engineering, quality systems, software quality, or related experience in a regulated environment.
Hands-on computerized system validation experience covering requirements, risk assessment, testing, traceability, deviations, and validation reporting.
Working knowledge of GxP/cGMP, FDA, ISO, data integrity, change control, CAPA, technical writing, and project execution.

Preferred Qualifications

Experience validating enterprise eQMS, laboratory, manufacturing, ERP, cloud/SaaS, reporting, integration, or data-migration solutions.
Experience with process/product validation, equipment, facilities and utilities qualification, cleaning validation.
Knowledge of ISO 9001, cGMP, FDA 21 CFR Parts 11, 210, 211, 820, Health Canada, ICH, Pic/s guidance, MHRA Data integrity
Multilingual communication capability, preferably English plus Spanish or Portuguese, and willingness to travel to manufacturing locations

Aplyr's read

Ecolab excels in providing essential water, hygiene, and energy solutions, attracting professionals committed to sustainability and innovation in environmental services.
Synthesized from recent postings & public sources

What's promising

•Ecolab leads in sustainable water and hygiene solutions, crucial for environmental safety.
•The company offers diverse roles, from technical to managerial, supporting career growth.
•Strong global presence ensures stability and opportunities for international work experience.

What to watch

•Ecolab's work can involve high-pressure environments due to client demands.
•Limited public information about internal career progression and employee satisfaction.
•The company faces challenges in balancing rapid growth with maintaining service quality.

Why Ecolab

•Ecolab integrates advanced technology with environmental services, setting it apart in the industry.
•Its focus on sustainability directly impacts global ecological health.
•The company's extensive client base spans multiple industries, offering varied professional experiences.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Ecolab

Ecolab

ecolab.com

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Ecolab is a global leader in water, hygiene, and energy technologies and services, providing comprehensive solutions to help businesses maintain clean and safe environments.