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Project Manager

2 months ago

Australia Cagents Full time
About Cagents

Cagents is a 100% employee-owned company established in 1996, with a global presence of over 850 people. We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness to FDA-regulated and other mission-critical industries.

Our Approach

We put the client's interests first, and we do not stop until it is right. We are committed to living our Foundational Principles, both professionally and personally:

  • We act with integrity
  • We serve each other
  • We serve society
  • We work for our future

We invest in our employees' future, providing hands-on certifications and professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.

Position Description

We are seeking a Project Manager to join our growing operations in Australia. The role of a Project Manager in Cagents is to:

  • Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients
  • Manage mid-sized to large projects related to process equipment and clean utilities, including start-up and commissioning
  • Lead design review, site acceptance, and installation of equipment
  • Write, review, and approve CQV documents following established 21 CFR standards, both internally and externally
  • Support onsite and offsite activities, such as FATs, SATs, executions, and system walkdowns
  • Manage any aspect of C & Q, verification as requested, i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management
  • Allocate project resources for efficient execution of project deliverables
  • Deliver the C&Q activities as required to meet the schedule
  • Track progress of C&Q activities as required and update dashboards
Position Requirements

The ideal candidate will have:

  • BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
  • 5+ years of Commissioning, Qualification, Validation, and Compliance experience in the Life Sciences or Regulated Industries; sound technical knowledge of TGA and global regulatory requirements
  • Experience in collaborating and managing Commissioning, Qualification, and Validation deliverables for one or multiple projects
  • Automation PM experience highly desired
  • Skilled at planning and tracking project activities and schedules
  • Excellent interpersonal skills to form strong relationships with internal and external clients
  • Excellent oral and written communication skills
  • Excellent problem-solving skills
  • Customer-service focused
  • High attention to detail
  • Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy, or equivalent experience
Other Requirements

The ideal candidate will also have:

  • Excellent oral and written English
  • Able to travel internationally or domestically if required
  • Able to work in Australia without sponsorship
What We Offer

In return for your skills and knowledge, Cagents offers a wide range of benefits, including:

  • Highly Competitive Salary
  • Continuing education (internal and external)
  • Opportunities to work on cutting-edge projects in a highly evolving field
  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries' applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries' applicable regulations)