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. Our services include cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing, and metrology services.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by offering a unique Employee Value Proposition, including the opportunity to work with talented professionals in the Pharma/Biotech industry. We provide permanent contracts that offer exposure 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. Our goal is to create high-performing teams that exceed client expectations in quality, efficiency, and timeliness.
Role Description
The successful candidate will provide process, technical, and validation support to manufacturing operations and process simulation development and execution. They will be responsible for studies related to new components, products, processes, systems, and facilities, including planning, design, and execution of simulations.
Requirements
Role Functions
* Serve as technical support for manufacturing and new product introduction.
* Design, review, approve, and execute process simulation studies for new products and manufacturing support.
* Contribute to quality investigations related to process simulations.
* Develop and validate process simulation documentation and studies in line with approval processes.
* Analyze data to inform decisions and recommendations.
* Support continuous improvement initiatives using Lean Six Sigma methodologies.
* Lead and participate in projects, investigations, and reports.
* Develop change controls for process simulations.
* Contribute to Kaizen events as appropriate.
* Perform root cause analysis of system failures using standard tools.
* Implement corrective actions through change management systems.
* Represent technical operations in internal and global forums.
* Collaborate with cross-functional teams and vendors.
* Ensure compliance with global policies, procedures, and cGMP standards, including participation in audits.
* Promote a safe and compliant work culture.
* Perform other duties as assigned.
Core Competences
Technical:
* Knowledge of regulatory requirements and standards.
* Report and policy writing skills.
* Equipment and process validation expertise.
* Knowledge of sterile filling processes and equipment.
* Proficiency in Microsoft Office and related applications.
* Lean Six Sigma experience preferred.
Business:
* Excellent communication, presentation, and interpersonal skills.
* Understanding of departmental responsibilities and business processes.
* Customer service and vendor liaison skills.
* Strong influencing, motivation, and adaptability skills.
* Effective time management and multitasking abilities.
* Attention to detail, troubleshooting, data analysis, and problem-solving skills.
* Training, change management, conflict resolution, negotiation, and project management skills.
* Business acumen and strategic thinking.
* People management and complex project management abilities.
Experience, Knowledge & Skills
Minimum Experience:
* Experience in aseptic sterile manufacturing preferred.
* Ability to coach and lead change.
* Strong knowledge of sterile manufacturing processes and results-driven in regulated environments.
Qualifications & Education
Minimum Education:
* Bachelor’s Degree or higher, preferably in Science, Engineering, or a related technical field.
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