Senior Commissioning & Qualification Engineer

Bachem

Senior C&Q Engineer leading commissioning and qualification for Bachem’s new Swiss peptide and oligonucleotide production site. Managing global CAPEX projects, GMP compliance, teams, budgets, and handovers.

Posted 8/5/2026full-timeSisslerfeld • 🇨🇭 SwitzerlandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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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 ExpertiseCAPEX Project ManagementGMP ComplianceGlobal Regulatory KnowledgeLean and Agile Methodologies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

C&Q ActivitiesProject ManagementRisk ManagementBudget ManagementExecution Strategy DevelopmentTender Document PreparationCost EstimationTechnical ReviewsSupplier EvaluationChange Management

Soft Skills

Excellent CommunicationCollaborationLeadershipAnalytical ThinkingFinancial Acumen

Tools & Technologies

KNEAT GxAutomation SystemsDigital Processes

Industry Keywords

Pharmaceutical IndustryBiopharmaceutical IndustryGMPNon-GMPBiologicsDrug SubstanceDrug ProductSmall MoleculesPackagingWarehousing

About the role

Key responsibilities & impact

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

What you’ll need

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

Benefits

Comp & perks

Exciting and challenging role in a dynamic and rapidly growing environment
Opportunity to make a lasting contribution to the company and the region
Diverse, multicultural team
Applications welcomed regardless of age, gender, background, religion, or sexual orientation