About PSC Biotech

Who are we? 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, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Position Summary

We are seeking a highly organized and technically capable Specialist, Engineering (Calibration Planner & Scheduler) to support and coordinate the site-wide Calibration and Gas Detection Programs. The role is responsible for the planning, scheduling, coordination, and performance management of calibration activities across all manufacturing, utility, laboratory, warehouse, and support areas. The successful candidate will act as the primary focal point for calibration planning activities, ensuring compliance with GMP requirements, maximizing equipment availability, optimizing contractor performance, and maintaining regulatory inspection readiness.

Responsibilities:

• Own the end-to-end planning and scheduling process for site calibration and gas detection activities.
• Develop and maintain weekly, monthly, quarterly, and annual calibration schedules.
• Coordinate calibration activities across manufacturing, laboratories, utilities, warehouse, and support functions.
• Create, plan, release, and manage calibration work orders within SAP and associated maintenance systems.
• Manage calibration backlog and drive timely closure of work orders.
• Coordinate site-wide calibration programs for instrumentation and gas detection systems.
• Lead the calibration daily meetings and maintain calibration KPI dashboards.
• Manage scheduling and coordination of external calibration vendors.
• Support audit readiness through maintenance of accurate records and planning documentation.
• Lifecycle management of Instruments.
• Drive improvements in planning, scheduling, and work management processes.

Leadership Expectations

Demonstrate ownership and accountability for calibration planning performance. Influence and support cross-functional initiatives. Drive a culture of compliance, reliability, and operational excellence.

GMP & Compliance Requirements

Comply with Global Policies, Procedures, and Guidelines. Execute current Good Manufacturing Practices (cGMP). Maintain inspection readiness and support regulatory inspections. 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, medical device or regulated manufacturing industries.
• Experience with ProCal or equivalent calibration management system.
• Knowledge of GMP, Data Integrity and regulatory inspection requirements.
• Knowledge of Instrumentation and Calibration Practices.

Core Competencies:

• Maintenance Planning & Scheduling
• Calibration Program Management
• SAP / CMMS Work Management
• Stakeholder Management
• Continuous Improvement
• Communication and Collaboration

Additional Information:

• Overtime : 10%
• Contract: 11 months
• Location: On-site for first 3 months; hybrid (1 day/week) thereafter
• Travel: None
• Experience: Pharma preferred; Medical Device experience desirable
• Reporting: Calibration Manager; part of a 12-person COE team
• Hours: 8:00 AM–4:00 PM
• Interview: On-site preferred; Teams acceptable