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.
Overview:
* The Delta V Technical Coordinator is responsible for managing and coordinating all technical activities related to the Emerson DeltaV Distributed Control System (DCS) Hardware and Software delivery to ensure compliant, reliable, and efficient automation of pharmaceutical API manufacturing processes.
* Familiarity with Agile Ways of working and support the implementation of the DeltaV Software Delivery through Agile methodology.
* Liaising with multiple cross functional Agile teams of System Integrators, Site Process and Operation Teams, Automation Engineers on a day-to-day basis to manage the progress of the sprint and to remove any roadblocks or impediments that the team is facing.
* Coordinate with the Scrum Master, Product Owner and System Integrator on a day-today basis to plan every sprint.
* Manage Technical Queries Log and updates
* Manage escalations to DeltaV Workstream Lead and PM as required
* Coordination of Software delivery to meet site DSAT dates.
* Responsible to maintain schedule adherence and to mitigate any delays.
* This role supports validation, regulatory compliance, and continuous improvement initiatives critical to Good Manufacturing Practices (GMP).
* API experience is preferable.
* Hybrid Role:3 days on site (Tuesday, Wednesday and Thursday) mandatory required
Requirements
Role Functions:
* System Coordination: Serve as the primary technical point of contact for all DeltaV DCS-related projects and operations within pharmaceutical manufacturing facilities.
* Implementation & Validation: Lead the implementation, configuration, and validation of DeltaV systems in accordance with FDA regulations, 21 CFR Part 11, and GMP guidelines.
* Configuration & Programming: Develop, configure, and test DeltaV control strategies, logic, and operator interfaces to meet pharmaceutical process requirements.
* Troubleshooting & Support: Provide expert troubleshooting and root cause analysis for DeltaV system issues, ensuring minimal downtime and compliance with quality standards.
* Documentation & Compliance: Maintain detailed documentation including system design specifications, validation protocols (IQ/OQ/PQ), change control records, and SOPs to support audits and regulatory inspections.
* Training: Train operators, engineers, and maintenance personnel on DeltaV system operation, change management, and compliance requirements.
* Vendor & Audit Coordination: Collaborate with Emerson, system integrators, and quality assurance teams during audits, inspections, and vendor assessments.
* Continuous Improvement: Identify and implement system enhancements to improve process control, data integrity, and operational efficiency while maintaining compliance.
* Risk Management: Participate in risk assessments and mitigation planning related to control system changes and upgrades.
* Ensure Automation compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Knowledge, Skills, Education & Location Requirements:
* Bachelor's degree in Electrical Engineering, Instrumentation, Automation, or related technical field.
* Extensive experience with Emerson DeltaV DCS in a pharmaceutical or highly regulated manufacturing environment.
* Strong knowledge of pharmaceutical manufacturing processes and regulatory requirements (FDA, EMA, 21 CFR Part 11, GAMP 5).
* Experience with system validation lifecycle (IQ/OQ/PQ) and documentation practices.
* Proficiency with DeltaV software tools (Control Studio, AMS Suite, DeltaV Operate).
* Familiarity with industrial networking, cybersecurity, and protocols relevant to pharma automation.
* Excellent communication, documentation, and project coordination skills.
* Ability to work effectively with cross-functional teams including Quality, Validation, Engineering, and Operations.
* Relevant certifications (e.g., DeltaV Certified Engineer, GAMP training) are highly desirable.