Job Overview
We are seeking an experienced Senior Pharmaceutical Commissioning and Qualification Specialist to join our team.
Key Responsibilities:
* Team Management: Manage a team of engineers on high-profile client sites throughout the project lifecycle, ensuring effective collaboration and communication.
* Commissioning and Qualification Expertise: Possess strong experience with Validation Master Plans, Commissioning Master Plans, project procedures, and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ).
* Design Review and GMP Risk Assessment: Conduct design reviews and have experience with GMP risk assessments (FMEA) to ensure alignment with regulatory requirements.
* Technical Documentation: Review and follow-up technical documentation from the early design phase to ensure compliance with GMP and CQV requirements.
* Troubleshooting and Resolution: Investigate and resolve technical issues with assistance from engineers and/or suppliers.
* Project Execution: Ensure site project execution is undertaken in compliance with company guidelines, department procedures, and safety standards.
* Scheduling and Progress Review: Prepare and review schedules and progress reports.
* CQV Activities Coordination: Organize and review daily activities of other CQV Engineers assigned to the project.
* Project Management: Apply project management principles to coordinate CQV activities and reporting to clients' project managers.
* Contractor and Vendor Management: Coordinate contractors and vendors.
Requirements:
* Education: Degree or equivalent in an engineering-related discipline.
* Experience: 10+ years of experience in commissioning and qualification activities for pharmaceutical facilities.
* Leadership and Teamwork: Demonstrate strong leadership and teamwork skills, liaising directly with clients and other project key functions.
* Management Experience: Previous experience as manager/leader of C&Q teams.
* Industry Knowledge: Strong knowledge of ISPE and ASTM E2500.
* International Projects: Proven experience with international pharmaceutical projects.
* Mentorship: Mentor junior staff members.