Senior Project Manager

4 days ago

Melbourne, Victoria, Australia beBeeLeadership Full time $180,000 - $200,000
Job Description

We are seeking a skilled professional to lead our commissioning, qualification, and validation (CQV) efforts in the life sciences industry.


Key Responsibilities
  • Provide cGMP leadership and guidance for the integration and delivery of CQV services.
  • Manage mid-sized to large projects related to process equipment and clean utilities.
  • Lead design review, site acceptance, and installation of equipment.
  • Write, Review, and Approve CQV documents following established 21 CFR standards.
  • Support onsite and offsite activities, such as FATs, SATs, executions, and system walkdowns.

Required Skills and Qualifications
  • 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. Proficient in cGMP standards.
  • 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.

Benefits

You will have an opportunity to work with recognized subject matter experts allowing you to be a key player in bringing lifesaving therapies to market.


Work Environment

Our team is dedicated to delivering high-quality results while ensuring a safe and healthy work environment.

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