Tech Transfer Engineer

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Carlow
• State/Province Carlow
• 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:

• Coordinate, execute & document qualification &process studies and additional product programs where applicable.
• Respond to operational and business areas, ensuring compliance with cGMP & regulatory requirements
• Accountable for compliance via documentation completion,risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance
• This role is a site-based/hybrid role
• This is a maternity cover for 11 months

Key Responsibilities:

• Generation, review and approval of process documentation.
• Execution of development and qualification studies across commercial and non-commercial product. Representing Technical Operations department at cross functional meetings.
• Development and qualification of new processes.
  
  Qualification of new equipment where appropriate.
• Lead & support investigations and troubleshooting ofprocess studies as required. Technical support for commercial manufacturing.
• Technical support for new product introduction.
• Ensure compliance with the QMS, industry/company specific standards and regulations. Demonstrate effective communication and interpersonal skills.
• Lead & support continuous improvement by active participation in, and contribution to, projects and problem-solving including use of MPS processes and tools.
• Application of technical knowledge to enable authoring of technical documents and technical decision making.
• Support audit readiness, including preparation of storyboards, ensuring GMP compliant documents are available, presentation to auditors as required.
• Work collaboratively to drive a safe and compliant culture.
• Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
• May be required to perform other duties as assigned.
• Demonstrate an awareness of own capabilities and development needs
• Proactively act to consistently improve personal knowledge and capability
• Drive business critical projects related to the Technical Operations department. Lead process initiatives/introductions as required.
• Provide expertise & technical support for cross functional programs & investigations Use expanded conceptual knowledge toprovide mentoring and guidance
• Understand the fundamental business drivers for the company; uses this knowledge in own work
• Drive to ensure that objectives are effectively achieved,consistent with regulatory requirements.
• Respond to & support operational and business areas,ensuring compliance with cGMP requirements.
• Ownership & management of change control and other compliance commitments.
• Drive continuous improvement by active participation in,and contribution to, projects and problem- solving including use…