LSC have an exciting contract opportunity for a Senior Validation Specialist to join a leading Biotech company based in Dublin.
If you have a minimum of 3 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Support the design, construction and qualification of the new Biotech Dublin facility and manufacturing science and technology laboratory by:
Developing and maintaining the site Validation Master Plan.
Driving completion of cleaning and sterilization cycle validation activities.
Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and revalidation.
Develop post OQ documentation in line with company and regulatory requirements.
Authoring and reviewing standard operating procedures and technical reports.
Supporting global regulatory submissions as needed.
o Applying LeanSixSigma in the Validation group by:
Securing continuity of an appropriate LSS/CEM level of knowledge.
Facilitate problem solving & risk assessment (FMEA) projects/meetings.
Making problems visible and strive for continuous improvement.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience)
o Experience with upstream cell culture and/or downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Conor Dolan at LSC on 021-4777329 if you have anymore questions about this Senior Validation Specialist opportunity!