PSC Biotech® Corporation

CQV Engineer (Passivation)

PSC Biotech® Corporation  •  Melbourne, AU (Onsite)  •  24 hours ago
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Job Description


POSITION SUMMARY:

The Commissioning, Qualification, and Validation (CQV) Engineer (Passivation)
is responsible for
ensuring systems, facilities, and equipment
meet
design requirements to be put in place for a facility.


Key Responsibilities


  • Commission, qualify, and
    validate
    facilities, utilities, and equipment
    in accordance with
    project and regulatory requirements.

  • Support the development, review, and execution of CQV documentation, including protocols, reports, and
    validation
    deliverables.

  • Assists
    to review and qualify equipment for commissioning, qualification, and validation activities.

  • Assist
    with equipment qualification activities and ensure systems meet design and operational requirements.

  • Participate in risk assessments, design reviews, FAT, SAT, IQ, OQ, PQ, and PV activities.

  • Collaborate with clients, contractors, vendors, and cross-functional teams to successfully deliver project
    objectives.


Requirements


Requirements


  • Bachelor's Degree in Engineering
    , Life Sciences, or
    a related
    discipline.

  • 2+
    years of experience in commissioning, qualification, and validation within pharmaceutical, biotech, or regulated environments.

  • Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation.

  • Experience developing SOPs, validation reports, and quality documentation.

  • Good understanding of cGMP requirements and 21 CFR compliance.

  • Previous
    experience with clean utility systems, particularly Purified Water (PW) and
    Water for
    Injection (WFI) systems.

  • Experience commissioning, pressure testing, flushing, passivating, and qualifying pharmaceutical water systems.

  • Knowledge of water system validation, sanitization, and lifecycle management activities.

  • Strong communication, problem-solving, and stakeholder management skills.
PSC Biotech® Corporation

About PSC Biotech® Corporation

Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. PSC Biotech Corporation serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services.

PSC Biotech Corporation has three unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, and BioTechnique™.

Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.

To learn more, visit our website.

Industry
Biotech & Life Sciences
Company Size
501-1,000 employees
Headquarters
Pomona, CA
Year Founded
Unknown
Website
biotech.com
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