Job Description

Key Responsibilities:

Develop and maintain detailed C&Q schedules using project planning tools (e.g., MS Project), aligned with overall project timelines. Collaborate with engineering, validation, QA, QC, and operations teams to plan and sequence commissioning and qualification 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.

Qualifications:

Bachelor's degree in Engineering, Life Sciences, or related field. Minimum 3 years of experience in project planning within a GMP-regulated pharmaceutical environment. Strong understanding of C&Q processes and lifecycle documentation (URS, DQ,IQ, OQ, PQ). Proficiency in project scheduling software (Primavera P6, MS Project, etc.). Familiarity with ISPE Baseline Guides and industry best practices for C&Q. Excellent communication, organizational, and stakeholder management skills.

Preferred Skills:

PMP or equivalent project management certification. Experience with large-scale pharmaceutical capital projects (e.g., new facility builds, equipment upgrades). Knowledge of computerized systems validation (CSV) and data integrity principles. * Experience with digital validation platforms (e.g. KNEAT) or eQMS systems.