Senior Commissioning & Qualification Engineer

Jobtailor; Aargau; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a senior C&Q lead to guide global CAPEX projects in the pharmaceutical/biopharma space. The role emphasizes GMP and regulatory alignment, cross-functional leadership, and rigorous execution of C&Q activities across biologics, drug substance, and drug product streams.

You will coordinate international teams, optimize commissioning strategies, and ensure smooth handover to operations while driving changes through global sites.

Qualifikationen

• Engineering or natural science degree.
• 10+ years in pharma/biopharma.
• International CAPEX projects experience.

Aufgaben

• Lead C&Q activities in large capital projects.
• Coordinate deviations and changes within timelines and quality standards.
• Manage budget, schedule, resources, and quality of C&Q execution.
• Develop C&Q execution strategies and detailed schedules.
• Prepare tender documents and estimate costs.

Kenntnisse

CQ Expertise

Project Management

Risk Management

Budget Management

Lean/Agile

Ausbildung

Engineering/Science degree

Tools

KNEAT Gx

Automation Systems

Digital Processes

Jobbeschreibung

• Lead C&Q activities within multidisciplinary large capital projects
• Coordinate and manage C&Q-related deviations and changes within defined timelines and quality standards
• Manage budget, schedule, prioritization, resources, and quality of C&Q execution
• Analyze options, plan execution strategies, and develop detailed C&Q schedules
• Prepare tender documents, support procurement processes, and estimate costs
• Ensure smooth handover to Operations and Quality
• Manage risk and derive proactive measures for deviations
• Manage and onboard C&Q teams and external partners
• Train C&Q teams and ensure adherence to internal standards
• Communicate clearly with stakeholders
• Collaborate with global sites to harmonize C&Q standards and digital processes
• Support supplier evaluation and coach local SMEs
• Promote lean and agile methods within engineering and C&Q
• Perform technical reviews in CAPEX projects
• Participate in or lead international teams in GMP engineering, C&Q, and global initiatives

Requirements

• Completed degree in engineering, natural sciences, or a related field
• At least 10 years of professional experience in the pharmaceutical or biopharmaceutical industry
• Proven experience in international CAPEX projects of medium to large scale with complex requirements
• Extensive C&Q expertise in biologics/drug substance, drug product, small molecules, packaging, warehousing, GMP and non-GMP infrastructure, automation systems, and new technologies
• Strong knowledge of global regulations including FDA, EMA, ICH, and ISPE Integrated Commissioning & Qualification
• Ideally experience with KNEAT Gx
• Deep understanding of project management, PQS/EM compliance, and interfaces with Quality
• Excellent communication, collaboration, and leadership skills
• Analytical thinking and financial acumen
• Willingness to drive change and support organizations through transformation
• Confident working style in global, culturally diverse teams

Core Competencies

Demonstrates extensive expertise in C&Q activities within large capital projects, with a strong focus on compliance with global regulations such as FDA and EMA. Proven ability to manage complex CAPEX projects, lead multidisciplinary teams, and drive organizational change in the pharmaceutical industry.

Highest-signal resume keywords

• C&Q Expertise
• CAPEX Project Management
• GMP Compliance
• Global Regulatory Knowledge
• Lean and Agile Methodologies

ATS Optimization Keywords

Hard Skills

• C&Q Activities
• Project Management
• Risk Management
• Budget Management
• Execution Strategy Development
• Tender Document Preparation
• Cost Estimation
• Technical Reviews
• Supplier Evaluation
• Change Management

Soft Skills

• Excellent Communication
• Collaboration
• Leadership
• Analytical Thinking
• Financial Acumen

Industry Keywords

• Pharmaceutical Industry
• Biopharmaceutical Industry
• GMP
• Non-GMP
• Biologics
• Drug Substance
• Drug Product
• Small Molecules
• Packaging
• Warehousing

Tools & Technologies

• KNEAT Gx
• Automation Systems
• Digital Processes