Commissioning and Qualification Engineer

About PSC Biotech Ltd

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:

Anamazingopportunity has arisen for aCQV (Commissioning, Qualification and Validation) Engineer BioNX,atourclients newstate of the artBiotech facility in Meath.

The new state of the art single use multi-product biotech facility in County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies.

This is a contingent position which will be responsible for the authoring and execution of the Performance Qualification (PQ) documents on site equipment and utilities including HVACs, Downflow Booths, Autoclaves, CTUs, Gases and Steam. The role is a combination of hands-on execution in the field and validation SME support for the project.

Responsibilities:

Plan and co-ordinate the performance qualification (PQ) activities for equipment and utilities in the BioNX project ensuring all projects are on schedule and meet the set timelines.

Effectively monitor and communicate the performance qualification activities and execution plan to other teams, project managers and key stakeholders.

Author, review and execute PQ protocols in line with Quality and Regulatory expectations

Author PQ reports in line with Quality and Regulatory expectations

Co-ordinate the day-to-day management of contractors where qualification activities are outsourced e.g. Temperature Mapping, HVAC qualification, Gas qualification, Autoclave qualification etc.

Manage performance qualification documentation, test scripts, qualification protocols, summary reports and risk assessments.

Perform validation SME reviews of vendor protocols.

Provide validation SME support for risk assessments and change controls.

Support the development of Standard Operating Procedures.

Focus on Customers, Including Patients.

Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs Collaborate.

Actively listen and seek to understand differing perspectives; work together to achieve the common goals.

Act with Candour and Courage.

Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions Make Rapid, Disciplined Decisions.

Make timely decisions at the right level with the right data and support them once made. Drive Results.

Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.

Demonstrate Ethics & Integrity.

Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies, and regulations; identify and address ethical issues without hesitation.

Requirements

Experience, Knowledge and Skills:

Experience developing validation documentation

Experience executing validation protocols

Experience closing out validation activities and writing validation reports

Project management experience a plus

Ability to analyse data and make recommendations

Experience in working with cross functional teams

Excellent report, standards, technical writing skills

Proficiency in Microsoft Office suite and job-related computer applications required

Qualifications:

Level 8 degree in a Science, Engineering or Other related Technical discipline