Job Title: Validation Engineer (Various Levels required)
- Support the design, construction and qualification of the new Dublin facility and manufacturing science and technology laboratory
- 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 MSD and regulatory requirements
- Authoring and reviewing standard operating procedures and technical reports
- Supporting global regulatory submissions as needed.
- 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.
- Serving as a key member during internal audits and external inspections/audits.
- Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
- Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
- Represent the site in internal collaborations through MMD Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
- Keep up to date with scientific and technical developments.
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
- Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry
- 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.
- Technical operations experience in the drug substance manufacture of biological molecules at the pilot- and/or commercial-scale.
- Prior experience in drug substance , process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
- Temperature Mapping Experience.
- Cleaning Validation Experience.
- Autoclave Experience.
For additional information or to submit your CV get in touch with Sarah : firstname.lastname@example.org