Technical Support Scientist - Fill Finish
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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, pharmaceutical 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 a 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 to 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 through learning & development in‑house training, mentorship, and constant guidance to facilitate career progression. We believe in creating high‑performing teams that can exceed our client’s expectations with regards to the quality of all scalable and business‑unit deliverables, staying under budget and ensuring timelines for our deliverables are met.
Responsibilities:
* Provide technical leadership within the Drug Product manufacturing team including areas such as formulation, filling, lyophilisation, capping and automated visual inspection.
* Execution of equipment qualification deliverables during project phase including equipment commissioning & qualification, IOQ.
* Coordinate technical deliverables within Drug Product to support the successful product launch.
* Provide technical support to the operations team during commercial manufacturing.
* Lead/participate in manufacturing investigations with cross‑functional teams to ensure that detailed root‑cause analysis is completed and appropriate CAPAs are implemented.
* Support batch disposition activities by providing SME technical support for comment resolution.
* Identify and implement projects to continuously improve compliance and manufacturing capabilities within the Drug Product.
* Support continuous process and quality improvements through the deployment of Lean Six‑Sigma tools.
* Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.
* In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DP organization.
* Participate in regulatory, client and internal audit inspections as the technical representative.
* Delegate for Manufacturing Technical Lead.
Requirements:
* Minimum 5 years working in a biological, vaccine or pharma facility. Preferred candidate will have cGMP with a biological, vaccine or pharma facility with prior sterile manufacturing experience.
* Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
* Experience with a data‑driven approach to root‑cause analysis and prioritization of continuous improvement initiatives, e.g., Six Sigma.
* Experience in leading & resolving complex technical investigations.
* Experience in a risk‑based approach to manufacturing through use of tools such as FMEA.
* Ability to adapt to changing priorities as project demands change.
Education:
* Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
Other skills:
o Previous experience in an operations role within vaccine manufacturing preferred.
o Knowledge of USP 1790 and industry/regulatory requirements such as Annex 1 desirable.
o Ability to explain complex technical issues to external customers/agencies.
o Experience with lyophilized products advantageous.
o Experience in start‑up facility advantageous.
o Demonstrated excellence in planning and organizational skills.
o Demonstrated skills in communication (oral and written) & in particular technical writing.
Seniority Level
Associate
Employment Type
Full‑time
Job Function
Other
Dundalk, County Louth, Ireland
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