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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in C&Q activities within large capital projects, with a strong focus on compliance with global regulations and project management. Proven ability to lead multidisciplinary teams, manage budgets, and drive change in the pharmaceutical and biopharmaceutical sectors.
Highest-signal resume keywords
C&Q ExpertiseProject ManagementGMP ComplianceInternational CAPEX ProjectsCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
C&Q ActivitiesProject ManagementRisk ManagementBudget ManagementExecution StrategiesTender Document PreparationSupplier EvaluationTechnical ReviewsLean MethodsAgile Methods
Soft Skills
Leadership SkillsAnalytical ThinkingCollaboration SkillsCreative ThinkingCommunication Skills
Tools & Technologies
KNEAT GxAutomation SystemsDigital ProcessesPQS/EM Compliance
Industry Keywords
Pharmaceutical IndustryBiopharmaceutical IndustryGMPNon-GMPIntegrated Commissioning & QualificationFDA RegulationsEMA RegulationsICH GuidelinesBiologicsDrug Substance
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 risks and derive proactive measures for deviations
- Manage and onboard C&Q teams, including external partners
- Train C&Q teams and ensure adherence to internal standards
- Communicate clearly and appropriately 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 in engineering and C&Q
- Perform technical reviews in CAPEX projects
- Participate in or lead international GMP engineering, C&Q, and global initiative teams
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 (medium to large scale, 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 (FDA, EMA, ICH, ISPE Integrated Commissioning & Qualification, etc.)
- 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, creative thinking, and ability to 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
- Equal opportunity workplace welcoming candidates regardless of age, gender, background, religion, or sexual orientation