CQV Engineer

Arcadis

Boston (MA)

On-site

USD 110,000 - 140,000

Full time

14 days+

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Benefits offered by this job

Medical

Dental

Vision

401K

Life insurance

Parental leave

Wellbeing benefits

Job summary

Arcadis is seeking a Validation Engineer to support commissioning, qualification, validation, requalification, and lifecycle management activities within a GMP-regulated pharmaceutical environment. You will develop and execute validation documentation and support capital projects, ensuring compliance with regulatory requirements.

The role requires coordinating cross-functional teams across Manufacturing, Facilities, QA, and Engineering, authoring IQ/OQ/PQ, FAT/SAT, and maintaining validated

Qualifications

Bachelor's degree in a relevant engineering discipline.
Experience in GMP-regulated pharma/biotech environments.
Experience authoring IQ/OQ/PQ, FAT and SAT protocols.
Knowledge of GMP, GDP, CQV principles and lifecycle.
Strong technical writing and documentation skills.
Ability to read engineering drawings and P&IDs.
Experience with cross-functional teams.

Responsibilities

Execute CQV activities for equipment, labs, facilities, utilities.
Create and review validation plans, RTMs, and reports.
Coordinate validation with Manufacturing, Facilities, QA, and Engineering.
Manage change controls, deviations, CAPAs, and non-conformance resolution.
Support audits and inspection readiness.
Assist with startup, commissioning of capital projects.

Skills

Technical writing

CQV knowledge

Cross-functional collaboration

GMP understanding

Education

Bachelor's degree in Engineering or related field

Job description

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.

We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world’s most complex challenges and deliver more impact together.

Arcadis is seeking a Validation Engineer to support commissioning, qualification, validation, requalification, and lifecycle management activities for manufacturing, laboratory, utility, facility, and quality systems within a GMP-regulated pharmaceutical environment. The Validation Engineer will be responsible for developing and executing validation documentation, supporting capital projects, managing change controls, coordinating cross-functional activities, and ensuring compliance with applicable regulatory, quality, and company requirements. This role supports equipment, utility, facility, and process validation activities from design through operational readiness.

Qualification & Validation

Execute commissioning, qualification, and validation (CQV) activities for manufacturing equipment, laboratory systems, facilities, and utilities.
Author, execute, and review FAT, SAT, IQ, OQ, PQ, requalification protocols, traceability matrices (RTMs), and validation reports.
Support periodic reviews, assessments, and requalification programs to maintain validated state.
Ensure validation activities are completed in alignment with GMP, quality, and regulatory requirements.
Support validation readiness for manufacturing operations and capital projects.

Technical Documentation

Develop, review, and update technical documentation including specifications, SOPs, risk assessments, investigations, engineering drawings, and validation deliverables.
Create and manage lifecycle documentation including User Requirements Specifications (URS), Functional Specifications, Impact Assessments, and Validation Summary Reports.
Review and provide redlines for engineering and validation documentation.

Technical Oversight & Coordination

Coordinate validation activities with Manufacturing, Facilities, Quality Control, Material Operations, Engineering, Automation, and Quality Assurance teams.
Monitor validation schedules and support achievement of department milestones and metrics.
Participate in technical reviews, risk assessments, project meetings, and mitigation planning activities.

Change Control & Quality Systems

Author, execute, review, and support GMP change controls.
Participate in deviation investigations, technical investigations, CAPAs, and non-conformance resolution activities.
Ensure all activities comply with company procedures, GMP requirements, and regulatory expectations.
Support audit and inspection readiness activities.

Capital Projects & Startup Support

Support commissioning, startup, and qualification activities associated with capital projects and facility expansions.
Assist with system turnover, operational readiness, and startup activities.
Support manufacturing operations during project execution, shutdowns, and system transitions.

Troubleshooting & Operational Support

Provide technical troubleshooting support during validation and qualification activities.
Investigate equipment, utility, process, and facility issues impacting qualification or manufacturing readiness.
Support continuous improvement initiatives to enhance compliance, reliability, and operational efficiency.

Facility Shutdown & Ongoing Operations

Support planned facility shutdown and startup activities.
Participate in operational and coordination meetings.
Provide status updates, progress reports, and performance metrics as required.
Support manufacturing operations during regular and off-shift activities as needed.
Other duties as assigned

Qualifications & Experience:

Bachelor's degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Mechanical Engineering, Electrical Engineering, Automation Engineering, Industrial Engineering, or a related scientific discipline.
Experience supporting validation and qualification activities in a GMP-regulated pharmaceutical, biotechnology, medical device, or life sciences environment.
Experience authoring and executing IQ, OQ, PQ, FAT, and SAT protocols.
Knowledge of GMP, GDP, CQV principles, and validation lifecycle requirements.
Experience with deviations, CAPAs, change controls, and quality systems.
Strong technical writing and documentation skills.
Ability to read and interpret engineering drawings, specifications, P&IDs, and equipment documentation.
Experience working cross-functionally with Engineering, Manufacturing, Quality, Validation, and Facilities teams.

Preferred Experience

Experience with clean utilities, HVAC systems, process equipment, laboratory instrumentation, and facility systems.
Experience with Building Management Systems (BMS), Environmental Monitoring Systems (EMS), SCADA, MES, LIMS, CMMS, and EDMS platforms.
Familiarity with FDA 21 CFR Parts 11, 210, and 211; EU GMP Annexes; GAMP 5; ISPE CQV guidance; and applicable industry standards.
Experience supporting startup, commissioning, and capital project activities.
Knowledge of cleanroom operations, aseptic processing, and regulatory inspection readiness.
Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

Why Arcadis?

We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It’s why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.

You’ll do meaningful work, and no matter what role, you’ll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.

Together, we can create a lasting legacy.

Join Arcadis. Create a Legacy.

Our Commitment to Equality, Diversity, Inclusion & Belonging

We want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.

Arcadis offers benefits for full time and part time positions.