Project Manager - Life Sciences

About the role

The Project Manager coordinates and oversees all aspects of a project so that it is completed on time and within budget, and is accountable for the project's execution and the PSC mission of maintaining the integrity and professionalism of its products and services while enabling steady growth. The role sits in the life sciences sector.

Key responsibilities

• Coordinate all aspects of assigned projects, including communication with internal and external vendors, and support cost and schedule management across multiple concurrent projects.
• Ensure the project is a functional plan that meets regulatory requirements and standards and is delivered on time, in line with management direction.
• Collaborate with client teams on commissioning and qualification, and support commissioning, qualification and validation (CQV) of facilities, utilities and equipment.
• Ensure system integration with filling lines and compliance with validation requirements.
• Initiate, author, revise and review controlled documents for CQV projects; write and review GMP/GDP documentation and technical specifications.
• Lead and coordinate risk analyses, design reviews and FAT, SAT, IQ, OQ and PQ; contribute to SOP development and final report reviews.
• Provide mentorship and consultation to clients and internal teams, and manage project timelines and deliverables.

Required profile

• Bachelor's degree in Chemical or Mechanical Engineering or a related life science degree; MBA or PM certification preferred.
• 7-10 years of related experience in the life sciences sector.
• 4+ years of project management in GMP-regulated environments.
• Minimum 3 years of expertise in CQV or fill-finish within GMP-regulated environments.
• Strong interpersonal skills and the ability to build relationships with a wide range of audiences.

Required skills

• Proficiency in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ and PV documents.
• Ability to develop SOPs, final reports and validation and quality policies.
• Understanding of cGMPs and data integrity guidelines.
• Knowledge of cost and risk management and project management methodologies.