Associate Technical Specialist

About PSC Biotech

Who we are?
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 Associate Technical Specialist will be required to collaborate and facilitate running of activities (e.g. support batch manufacture and licence submissions) in the Vaccines IPT value stream for Technology Transfer of processes to ensure the effective and efficient on-time delivery of these activities to Vaccines IPT.

This requires the delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.

Responsibilities:

Ensure the highest Quality, Compliance and Safety standards primarily with Technology Transfer but relating to all activities.

Work within a team to enable the team s performance within the Technology Transfer team

Support the technical transfer and provide technical support to manufacturing operations.

Preparation and review of Qualification protocols (IQ, OQ and PQ)

Analyses the results of testing and determines the acceptability of results against predetermined criteria.

Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.

Contribute for driving a culture of Continuous Improvement by deploying Six Sigma tools within the IPT on projects such as: problem solving, reducing cycle time, Lean principles within the new processes.

Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

Participate and comply with the Quality Management System (QMS) requirements

Requirements

Experience:

1-2 years experience in biopharmaceutical/vaccines environment

Trackwise/ SAP experience would be an advantage

Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.

Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.

Experience in an FDA / HPRA Regulated production environment desirable.

Qualifications:

Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).

Strong problem-solving, collaboration, and written and oral communication skills.

Strong organizational, interpersonal, writing, and time management skills.

Proven ability to work independently Self-motivated and collaborate effectively as part of a team.

Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory