20 Aug
|
Recognized
|
Brisbane
20 Aug
Recognized
Brisbane
POSITION SUMMARY:
The Manufacturing Engineer is responsible for supporting and ensuring systems, facilities, and
equipment meets the design requirements to be put in place for a facility. 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:
- Collaborated
with client teams to deliver CQV project objectives, managing timelines,
dashboards, and status reporting to PSC Project Managers.
- Executed
commissioning, qualification, and validation (CQV) activities, including
FAT/SAT, IQ/OQ/PQ, risk assessments, and design reviews for facilities,
utilities, and equipment.
- Authored
and reviewed controlled GMP documentation, including SOPs, GDP records,
validation protocols, reports, and technical specifications.
- Supported
equipment and system implementation, driving process improvements and ensuring
compliance with cGMP requirements.
- Facilitated
cross -functional project delivery, coordinating stakeholders, vendors, and
contractors to achieve project milestones.
- Led
operator training and operational readiness activities,
ensuring personnel
competency and alignment with quality systems.
- Supported
CQV and operation of single -use bioreactor (SUB) systems, including setup,
troubleshooting, and compliant performance.
- Provided
mentoring and technical guidance to client teams and junior staff across
project activities.
- Contributed
to continuous improvement initiatives to enhance quality, compliance, and
operational efficiency across projects.
Requirements
- Bachelor’s Degree in Engineering or Life Science.
- 3 -5 years of applicable work experience in the
biomedical and pharmaceuticals industry.
- Min 2 years of expertise in CQV
- Proficient in authoring and executing DQ, FAT, SAT,
IQ, OQ, PQ, and PV documents.
- Proficient in developing SOPS, final reports and
validation & quality policies.
- Understanding of developing, executing and maintaining
CQV procedures and policies.
- Has positive understanding and complies to cGMPs and Data
Integrity guidelines.
- Knowledge of Bioprocess Manufacturing Operation in GMP Facility
- Experience with Smartsheet's, SOP, Track wise, or
similar systems
- Familiarity with Delta V control and CAD software
preferred.
- Excellent presentation and communication skills,
written and oral, for a variety of audiences.
- Highly organized in planning and time management, with
the ability to multi -task.