About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US. We serve 350 clients in more than 23 countries worldwide, providing cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by offering a unique Employee Value Proposition, providing opportunities to work with talented professionals in the Pharma/Biotech industry. We offer permanent employment, exposing employees to top pharmaceutical client sites in diverse cultural settings.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech. We offer empowering career development through in-house training, mentorship, and continuous guidance to facilitate career growth. We aim to create high-performing teams that exceed client expectations in quality, stay within budget, and meet deadlines.
Overview
As part of the IPT team, perform production and operations tasks to support manufacturing and ensure reliable supply of products. Ensure objectives are met, maintaining compliance, safety, and customer satisfaction.
This is a shift role, 24/7 onsite.
Requirements
Role Functions:
1. Operate and monitor production activities and support equipment using MES/DCS and PLC systems, ensuring optimal equipment uptime and output. Equipment includes, but is not limited to, parts washers, autoclaves, CIP/SIP tanks, Vial Washer, Depyro Tunnel, Debagger, and filling machines.
2. Maintain clean room standards, housekeeping, and materials management, focusing on continuous process improvement using Lean principles.
3. Manage equipment flow, tracking soiled and clean hold times, labeling, and inventory using Kanbans and MES systems to ensure QC status and expiry management.
4. Perform preventative maintenance, troubleshooting, and repairs on process equipment where qualified.
5. Contribute to writing and revising operational procedures and training materials, supporting continuous improvement initiatives, investigations, change control, and Kaizen projects. Use root cause analysis tools to resolve issues and implement corrective actions.
6. Comply with global policies, procedures, and regulatory requirements, executing cGMP activities daily.
7. Promote a safe and compliant work culture.
8. Perform additional duties as assigned.
Experience, Knowledge & Skills:
Technical:
* Experience with sterile filling processes and equipment.
* Knowledge of regulatory requirements per Irish, European, and international standards.
* Skills in report writing, policy development, and proficiency in Microsoft Office and related applications.
Business:
* Effective communication and interpersonal skills.
* Understanding of departmental responsibilities and business processes.
* Customer service orientation, self-motivation, flexibility.
* Time management, multi-tasking, attention to detail, troubleshooting, goal orientation, and training skills.
Leadership:
* Customer and patient focus.
* Collaboration and integrity.
* Decisiveness, results-driven, talent development, ethical conduct.
Qualifications & Education:
Minimum Education:
* Leaving Certificate or equivalent.
* Preferred: Apprenticeship, Certificate, or Diploma in a related discipline.
Experience:
* Prior related work experience, ideally in manufacturing or GMP settings.
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