- Industry Pharma/Biotech/Clinical Research
- Work Experience 4-5 years
- City Carlow
- State/Province Carlow
- Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Position Summary
- We are seeking a highly organized and technically capableSpecialist, Engineering (Calibration Planner & Scheduler) to support andcoordinate the site-wide Calibration and Gas Detection Programs. The role isresponsible for the planning, scheduling, coordination, and performancemanagement of calibration activities across all manufacturing, utility,laboratory, warehouse, and support areas.
- The successful candidate will act as the primary focalpoint for calibration planning activities, ensuring compliance with GMPrequirements, maximizing equipment availability, optimizing contractorperformance, and maintaining regulatory inspection readiness.
Requirements
Responsibilities:
- Own the end-to-end planning and scheduling process forsite calibration and gas detection activities.
- Develop and maintain weekly, monthly, quarterly, andannual calibration schedules.
- Coordinate calibration activities across manufacturing,laboratories, utilities, warehouse, and support functions.
- Create, plan, release, and manage calibration work orderswithin SAP and associated maintenance systems.
- Manage calibration backlog and drive timely closure ofwork orders.
- Coordinate site-wide calibration programs forinstrumentation and gas detection systems.
- Lead the calibration daily meetings and maintaincalibration KPI dashboards.
- Manage scheduling and coordination of externalcalibration vendors.
- Support audit readiness through maintenance of accuraterecords and planning documentation.
- Lifecycle management of Instruments.
- Drive improvements in planning, scheduling, and workmanagement processes.
- Demonstrate ownership and accountability for calibrationplanning performance.
- Influence and support cross-functional initiatives.
- Drive a culture of compliance, reliability, andoperational excellence.
GMP & Compliance Requirements
- Comply with Global Policies, Procedures, and Guidelines.
- Maintain inspection readiness and support regulatoryinspections.
- Adhere to Data Integrity and ALCOA+ principles.
Required Qualifications
- Degree or Level 7 qualification in Engineering,Instrumentation, Maintenance Management or related discipline.
- Minimum 3 years experience in planning, scheduling,maintenance, calibration, or engineering support within a GMP environment.
- Experience using SAP or equivalent CMMS/EAM system.
Preferred Qualifications:
- Experience within pharmaceutical, biotechnology, medicaldevice or regulated manufacturing industries.
- Experience with ProCal or equivalent calibrationmanagement system.
- Knowledge of GMP, Data Integrity and regulatoryinspection requirements.
- Knowledge of Instrumentation and Calibration Practices.
Core Competencies:
- Maintenance Planning & Scheduling
- Calibration Program Management
- SAP / CMMS Work Management
- Stakeholder Management
- Communication and Collaboration
Additional Information:
- Overtime: 10%
- Contract: 11 months
- Location: On-site for first 3 months; hybrid (1day/week) thereafter
- Travel: None
- Reporting: Calibration Manager; part of a12-person COE team
- Hours: 8:00 AM–4:00 PM
- Interview: On-site preferred; Teams acceptable