Process Validation Engineer

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Cork
• State/Province Cork
• Country Ireland

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in morethan 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 modelby 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 adiverse-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 ourclient’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:

• This position reports to the Process Validation Manage rand is responsible for multi-modality process validation activities in a cGMPenvironment. This position will coordinate and manage process validationprojects related to the implementation of new manufacturing processes and changes to existing processes according to the three phases of process validation. Process validation activities may include drug substancemanufacturing processes, drug product filling processes and completion of validation risk/impact assessments and evaluations, etc.
• The position organizes and performs process validation activities with general supervision within a cross-functional cGMP environment while fostering a collaborative Team environment. Other responsibilities ofthis position include project management, protocol generation, protocolexecution, final summary report generation, CTD module generation and review,and other duties as assigned.

Responsibilities:

• Perform process validation activities related to drug substance and drug products, throughdefined clinical and commercial stages.
• Execute (protocol generation, execution, and finalpackage preparation) process validation activities related to the implementation of process changes and new processes while exercising supervisedjudgment within broadly defined procedures and practices to establishacceptance criteria, and to identify and implement solutions to meet Health Authority requirements.
• Assist with preparation of regulatory filings, withanswering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
• Development and implementation of SOPs/Guidelinedocuments with systemic procedural improvements.
• Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures.
• May participate on sub-teams.
• Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by client,validation techniques/approaches and systems utilized
• Participate in multi-departmental meetings & project teams.
• Identifies and assists with implementation of improvements to Process Validation systems (department level impact).
• Generation of process validation master plans, corevalidation master plans and additional supporting documentation.
• Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal laboratories.
• Coordination of process validation activities involvingcross-functional, multi-departmental teams including Manufacturing , Technical Development, Quality Control,…