PSC Biotech→
Project Manager - Melbourne at PSC Biotech in Melbourne, Victoria, AU
Skills
Job Description
POSITION SUMMARY:
The Project Manager is to coordinate and oversee all aspects of a project to ensure it is completed on-time and within budget. The incumbent is also responsible and accountable for the execution of the project and PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development”.
DUTIES AND RESPONSIBILITIES:
Coordinating all aspects of assigned projects included communication with internal and outside vendors.
Support cost and schedule management across multiple concurrent projects. Ensure the project is a functional plan, meets regulatory requirements and standards, and is delivered in a timely manner.
Execute project implementation in alignment with management direction.
Demonstrate technical aptitude and cross-disciplinary knowledge, with strong computer proficiency.
Collaborate with client teams on commissioning and qualification activities aligned with project goals.
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.
Partner with cross-functional teams to deliver project activities and milestones.
Lead and coordinate risk analyses, design reviews, and execution of FAT, SAT, IQ, OQ, and PQ.
Contribute to SOP development and final report reviews.
Provide mentorship and consultation to clients and internal teams.
Manage project activities, timelines, and deliverables effectively.
Additional duties and responsibilities may be assigned from time to time.
DEMONSTRATED COMPETENCIES:
Relationship Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry.
Negotiation Skills – Active listening, needs assessment, and presents visions to build a consensus.
Organization – Strong organization skills are needed to assist in personnel, budgets, and planning for each project.
Analytical Skills – Identifies, researches, and demonstrates logical reasoning to communicate critical information.
Rational Persuasion – Presents key factors, influencing factors, and strategic goals to assist stakeholders in identifying solutions.
Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes.
Agility – Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines.
Requirements
REQUIRED EDUCATION AND WORK EXPERIENCE:
Bachelor’s Degree in Engineering (Chemical or Mechanical) or Life Science relative degree preferred.
MBA or PM Certification preferred.
7-10 years of related experience in Life Science sector
4+ years’ experience with project management in GMP-regulated environments.
Min 3 years of expertise in CQV or Fill Finish within GMP-regulated environments.
Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
Proficient in developing SOPS, final reports and validation & quality policies.
Understanding of developing, executing and maintaining CQV procedures and policies.
Has good understanding and complies to cGMPs and Data Integrity guidelines.
Understanding of cost and risk management skills and various project management methodologies.
Evaluate and identify challenges and utilize resources to solve problems.
Exceptional interpersonal skills to effectively communicate and build relationships with a broad spectrum of audiences at all organizational levels.
Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality.