The Manufacturing Engineer is responsible for supporting and ensuring systems, facilities, and equipment meet 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 good 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.
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