Description
Are you a Technical Service Specialist interested in working for one of Irelands leading names in High-Tech Pharmaceutical Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!
Title: Technical Service Specialist
Rate: Negotiable
Location: Dublin, Ireland
Positions Available: 1 Engineer
Type: Contract (12 Months Rolling)
A Fantastic new role has just opened up at one of our leading Irish based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
The proposed start date is ASAP - We need YOU
Responsibilities include:
- To provide process expertise in the area of buffer/media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors) to support the successful startup of the company's BDS facility in Dublin.
- Working knowledge of typical cell culture unit operations, cause and effect, product expression, in-process tests.
- Responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility.
- Accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Process Owner for cell culture unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies/SME capability.
- To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents.
- To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies.
- To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
- To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
- To identify and implement process improvements; eg yield, cycle time reduction.
- To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
- May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution.
- To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.
- Lead any key process changes using change control management system.
- Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
- Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations.
- To author and review IND, BLA and other technical documents for regulatory agency submissions.
- To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.
Requirements:
- Minimum 5 years' experience in Technical Services/Process Development/Manufacturing support in a biologic bulk drug substance manufacturing organization
- Technical and operational knowledge of multiple unit operations in cell culture processing
- In-depth technical and operational knowledge of multiple unit operations in upstream processing, including media preparation, mammalian cell culture, centrifugation and depth filtration
- Strong understanding of technology transfer, scale-up process and cleaning validation
- Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant
- Experience of Validation/Verification of GMP equipment or processes would be beneficial
If you are interested please do not hesitate to email or call me!
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