Commissioning Engineer

The Commissioning Engineer will be responsible for the planning, execution, and documentation of the commissioning activities related to a pharmaceutical manufacturing facility build project. This role ensures that all systems and equipment are installed, tested, and verified to meet project specifications, regulatory standards, and operational readiness. The candidate will work closely with engineering teams, contractors, validation teams, and regulatory bodies to ensure seamless commissioning.

Key Responsibilities

Commissioning Plan Development:
- Develop detailed commissioning plans, including timelines, procedures, and checklists for critical systems (HVAC, water systems, utilities, cleanrooms, etc.).
- Ensure the commissioning plan aligns with project timelines, engineering designs, and regulatory requirements (FDA, GMP, EU GMP).
Equipment and Systems Commissioning:
- Coordinate and perform commissioning activities for process equipment (bioreactors, filtration systems, sterilizers), utilities (WFI, clean steam), and support systems (HVAC, electrical, fire protection, etc.).
- Execute Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and ensure installation qualifications (IQ) are complete.
Collaboration & Coordination:
- Collaborate with cross-functional teams including design engineers, contractors, vendors, and validation engineers to ensure equipment is correctly installed, tested, and operates as per design specifications.
- Coordinate with external contractors and vendors for scheduling and performing commissioning tasks.
Testing & Troubleshooting:
- Conduct operational tests and troubleshoot any issues related to equipment, system performance, or compliance with regulatory standards.
- Support issue resolution by identifying root causes and implementing corrective actions during commissioning activities.
Documentation & Compliance:
- Ensure all commissioning documentation, including protocols, reports, and deviations, is completed and in compliance with regulatory standards (GMP, FDA).
- Maintain detailed records and generate commissioning reports for each system, including testing results, calibration data, and any deviations or changes.
- Support the qualification and validation process, ensuring that systems are qualified and validated according to project and regulatory requirements.
Handover & Operational Readiness:
- Ensure smooth handover of commissioned systems to the validation team and operations staff.
- Conduct training for operational staff on newly commissioned equipment and systems.
- Provide support for the start-up and initial operation phases of the facility, ensuring all systems are fully operational and meet production needs.
Regulatory & Quality Assurance:
- Ensure compliance with industry regulations, standards, and guidelines, including cGMP, FDA, EU GMP, and other relevant authorities.
- Conduct regular audits of commissioning activities to ensure adherence to project specifications and regulatory standards.

Requirements

Qualifications

Bachelor’s Degree in Mechanical, Electrical, Chemical Engineering, or related field.
Professional certifications in commissioning or project management (CCP, PMP) are a plus.
10+ years of experience in commissioning engineering roles, ideally within pharmaceutical manufacturing or highly regulated industries.
Experience with commissioning process equipment, utilities, HVAC, and automation systems in GMP-compliant environments.
Familiarity with regulatory standards (FDA, EU GMP, ISPE, etc.).
Strong knowledge of process systems, utility systems, and cleanroom environments within pharmaceutical manufacturing.
Proficiency in reviewing engineering drawings, P&IDs, and technical documents.
Hands-on experience with commissioning software tools and databases (e.g., Building Management Systems, SCADA).

Key Competencies

Attention to detail and commitment to quality.
Strong organizational and project management skills.
Ability to work collaboratively in a cross-functional team.
Knowledge of safety protocols and regulatory compliance requirements.

Physical Requirements

Ability to travel to various locations within the facility or vendor sites.
Ability to work in a cleanroom environment.

Soft Skills

Cross-Cultural Communication
Adaptability and Flexibility
Team Collaboration and Interdisciplinary Skills
Problem-Solving and Critical Thinking
Emotional Intelligence
Time Management and Prioritization
Ethical Awareness and Sustainability Focus
Conflict Management
Stakeholder Engagement
Continuous Learning Mindset

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General Information

Vacancy: 013

Location: Europe

Contract type: 1 year rolling contract, consulting contract.

Project duration: 1-2 years.

How to Apply?

If you’re interested in this role, we’re looking forward to hear from you! Kindly apply via the JTR Consultancy Services website with your CV in Word Document version – one of our Business Development Managers will be in touch with you shortly.