Job description
ABOUT THE JOB
- Develop and maintain detailed commissioning and qualification (C&Q) schedules using project planning tools, aligned with overall project timelines
- Collaborate with engineering, validation, QA, QC, and operations teams to plan and sequence C&Q activities
- Monitor progress, identify schedule risks, and implement mitigation strategies to ensure timely delivery of C&Q milestones
- Support the development and execution of C&Q strategies, including URS, DQ, IQ, OQ, and PQ documentation and activities
- Ensure C&Q activities comply with GMP, FDA, EMA, and other applicable regulatory standards
- Facilitate planning meetings, progress reviews, and reporting to project stakeholders
- Coordinate resource planning and availability for C&Q tasks, including vendor and contractor support
- Maintain accurate documentation and change control records related to C&Q scope
- Support audits and inspections by providing schedule-related documentation and insights
ABOUT YOU
- Academic background: Bachelor’s degree in Engineering, Life Sciences, or related field
- Minimum 3 years of experience in project planning within a GMP-regulated pharmaceutical environment
- Proficiency in project scheduling software (Primavera P6, MS Project, etc.)
- Strong understanding of C&Q processes and lifecycle documentation (URS, DQ, IQ, OQ, PQ)
- Familiarity with ISPE Baseline Guides and industry best practices for C&Q
- Experience with digital validation platforms (e.g. KNEAT) or eQMS systems
- Experience with large-scale pharmaceutical capital projects (e.g., new facility builds, equipment upgrades)
- Knowledge of computerized systems validation (CSV) and data integrity principles
- PMP or equivalent project management certification is a plus
- You have excellent communication, organizational, and stakeholder management skills
WHY AMARIS?
At Amaris Consulting, we believe in creating a thriving, positive workplace where every team member can grow, connect, and make a real impact.
Here’s what you can expect when you join our dynamic community:
- Global Diversity: Be part of an international team of 110+ nationalities, celebrating diverse perspectives and collaboration.
- Trust and Growth: With 70% of our leaders starting at entry-level, we’re committed to nurturing talent and empowering you to reach new heights.
- Continuous Learning: Unlock your full potential with our internal Academy and over 250 training modules designed for your professional growth.
- Vibrant Culture: Enjoy a workplace where energy, fun, and camaraderie come together through regular afterworks, team-building events, and more.
- Meaningful Impact: Join us in making a difference through our CSR initiatives, including the WeCare Together program, and be part of something bigger.