PSC Biotech® Corporation

Computer Systems Validation (CSV) Engineer - Brisbane

PSC Biotech® Corporation  •  Brisbane, AU (Onsite)  •  3 months ago
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Job Description


We are looking for a Computer Systems Validation (CSV) Engineer to join our team on a

12-month contract

.

The CSV Engineer will be responsible for assisting in planning, writing, implementing, and reviewing validation protocols for computer-based systems. The person is responsible for making sure computer-based systems are operating as intended and meet regulatory requirements. The incumbent is also responsible and accountable for the execution of the PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”

DUTIES AND RESPONSIBILITIES:

  • Write, review, and approve validation procedures, documents, test scripts and final reports in compliance with company policies and standards from regulatory agencies.

  • Assists to maintain accurate validation documentation.

  • Keep up to date with advances in the field and the regulatory requirements.

  • Support involvement in review and updating of validation documentation.

  • Assist in reviewing and analysing validation data – compiling reports when required.

  • Recommendation of process upgrades and improvements in efficiency.

  • Support the implementation of such improvements with upper management.

  • Assist in involvement in both internal audits and external inspections as required.

  • Additional duties and responsibilities may be assigned from time to time.


Requirements


  • Bachelor’s Degree in Computer Science or Engineering or equivalent experience.

  • 2-5 years of experience in computer systems validation experience.

  • Demonstrated strategic thinking, implementation skills, and ability to drive results.

  • Strong attention to details.

  • Ability to follow protocols and procedures.

  • Excellent written and oral presentation and communication skills.

  • Highly organized in planning and time management, with the ability to multi-task.

  • Ability to work with a team or independently.

  • Has experience writing, reviewing, and executing validation documentation, IQ, OQ, PQ, RTM, Test Scripts, Summary Reports.

  • Knowledge of operating systems and MS Office desired.

  • Knowledge of regulatory, compliance, and validation desired.

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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
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