Commissioning Engineer

Vulcain Engineering Group; Frankfurt; Vor Ort; EUR 75.000 - 110.000; Vollzeit

Zusammenfassung

Vulcain Engineering Group seeks an experienced CQV professional to lead commissioning and qualification activities for complex pharmaceutical and biotechnology projects in Germany. The role requires coordinating cross-functional teams, ensuring GMP compliance, and delivering documentation and turnover packages.

You will develop strategies, manage interfaces among engineering, construction, CQV, operations and quality, and drive continuous improvement in CQV practices.

Qualifikationen

• 5+ years of experience in CQV, commissioning, validation, or project engineering in pharma/biotech.
• Experience on GMP-regulated projects is required.
• Experience coordinating contractors, vendors and cross-functional teams is essential.

Aufgaben

• Lead commissioning and qualification activities for utility systems on pharmaceutical/biotech projects.
• Develop and execute commissioning strategies, protocols, and turnover packages.
• Coordinate multidisciplinary teams during commissioning, start-up, and qualification phases.
• Support FAT, SAT, installation verification, commissioning, and qualification activities.
• Manage interfaces between engineering, construction, CQV, operations and quality teams.
• Ensure systems are delivered per schedules, quality standards, and regulatory requirements.
• Review and approve technical documentation, test reports and qualification deliverables.
• Participate in risk assessments, deviation management and change control processes.
• Provide technical troubleshooting support during start-up and operational readiness.
• Contribute to continuous improvement initiatives and CQV best practices.

Kenntnisse

CQV

Commissioning

GMP

Stakeholder management

Team coordination

Quality documentation

Ausbildung

Bachelor’s or Master’s degree in Electrical Engineering / Process Engineering / Biotechnology / Pharmaceutical Engineering

Jobbeschreibung

Your responsibilities

• Lead commissioning and qualification activities for utility systems on pharmaceutical and biotechnology projects.
• Develop and execute commissioning strategies, protocols, and turnover packages in compliance with GMP requirements.
• Coordinate multidisciplinary teams during commissioning, start-up, and qualification phases.
• Support FAT, SAT, installation verification, commissioning, and qualification activities.
• Manage interfaces between engineering, construction, CQV, operations, and quality teams.
• Ensure systems are delivered in accordance with project schedules, quality standards, and regulatory requirements.
• Review and approve technical documentation, test reports, and qualification deliverables.
• Participate in risk assessments, deviation management, and change control processes.
• Provide technical troubleshooting support during start-up and operational readiness phases.
• Contribute to continuous improvement initiatives and CQV best practices across projects.

Your profile

• Bachelor's or Master\'s degree in Electrical Engineering, Process Engineering, Biotechnology, Pharmaceutical Engineering, or a related discipline.
• Minimum 5 years of experience in CQV, commissioning, validation, or project engineering within the pharmaceutical or biotechnology industry.
• Strong experience working on GMP-regulated projects.
• Proven experience in greenfield and brownfield facility environments.
• Knowledge of qualification lifecycle, commissioning methodologies, and validation requirements.
• Experience coordinating contractors, vendors, and cross-functional project teams.
• Ability to review technical documentation, drawings, and system design packages.
• Strong understanding of pharmaceutical utilities, process equipment, and facility systems.
• Excellent communication and stakeholder management skills.
• Fluent English is required; German is considered a strong advantage.