Proclinical is seeking an experienced Commissioning & Qualification Engineer to join our client, a global biopharmaceutical leader recognised for its innovation and commitment to delivering life-changing medicines to patients worldwide.
Based at their Broadmeadows site, the business manufactures life‐saving plasma‐derived and recombinant therapies and continues to invest in major capital projects to expand, modernise and strengthen its manufacturing capability.
About the Role
Reporting to the C&Q Senior Principal within the core Commissioning & Qualification project team, the Commissioning & Qualification Engineer is responsible for the planning, developing and executing commissioning and qualification activities of automated pharmaceutical processing equipment for a major facility project in line with site, industry, GxP and regulatory standards.
This role will suit someone who is technically strong, proactive, confident working with stakeholders, and comfortable translating project requirements into detailed test plans and qualification packages.
* Team Size: Project team in C&Q of 4 (includes manager and 3 other leads). Additional resources during peak periods
* Duration: 12-month contract (strong potential to extend)
* Start Date: ASAP
* Hours: Standard Monday to Friday hours; During shutdowns may need to work weekends, possibly early morning or an afternoon shift
* Capacity: All on‐site
Key Responsibilities
* Plan, coordinate and manage qualification activities for automated pharmaceutical processing equipment.
* Generate test scripts, protocols and qualification documentation.
* Execute qualification testing on site, including FAT, SAT, DQ, IV and OV activities.
* Review and provide input into GxP documentation including URS, risk assessments and change controls.
* Translate C&Q plans into detailed test plans for allocated systems and process areas.
* Support delivery of qualification packages for assigned plant/process areas.
* Coordinate resources and project activities to ensure work is delivered to schedule.
* Work collaboratively with Process Engineering, Project Delivery, Execution Systems, Validation, Stability, Value Streams, R&D, QC and other stakeholders.
* Read and interpret technical drawings, engineering documents and process information.
* Identify issues, ask the right questions and challenge appropriately to support compliant project delivery.
Skills and Experience
* Relevant tertiary qualification in Science or Engineering, ideally Chemical, Mechanical or Bioprocess Engineering.
* 5+ years' experience in commissioning and qualification within a pharmaceutical or GMP‐regulated environment.
* Strong understanding of pharmaceutical processing equipment and associated qualification requirements.
* Experience generating and executing C&Q protocols, test scripts and qualification documentation.
* Experience with FAT, SAT, DQ, IV, OV and related qualification activities.
* Good understanding of GxP, validation principles, risk assessments, URS and change control.
* Ability to read technical drawings and engineering documentation.
* Strong stakeholder management skills and confidence working across cross‐functional project teams.
* Proactive, solutions‐focused approach with the ability to manage competing priorities.
* Strong written and verbal communication skills.
Proclinical Staffing is an equal opportunity employer.
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