Senior Recruitment Consultant at PE Global
PE Global is recruiting for a Tech Transfer Engineer for our biopharmaceutical client in Dundalk. This is an initial 12-month contract, fully onsite role.
The Manufacturing Science and Technology (MS&T) – Drug Product Technical Operations (DS Tech Ops) organization is seeking a highly motivated individual for a Technology Transfer position. DP Tech Ops is accountable for technology transfers and commercial production of finished Drug Product at our Dundalk site. This person will have the opportunity to participate in all areas of Tech Ops. This may include supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity optimization.
Responsibilities
Work with Internal Partners to achieve business goals.Provide support within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection.Responsible for process ownership, demonstrating technical excellence as the subject matter expert (SME) for drug product processesResponsible for technical activities for the commercial manufacturing process, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.Responsible for technology transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.Provide on-site coverage in support of Commercial and / or Technology Transfer Person-In-Plant Activities.Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations and QualityEnsure that Site is inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.Responsible for participation in creating, sharing, and adopting best practices and business process strategies.Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Required Experience and Skills
Minimum of 3 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or MaintenanceStrong communication in English and teamwork skills
Preferred Experience and Skills
Proven expertise in aseptic operations, analytical testing, process development and tech transfer.Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirableExperience with lyophilized products advantageousExperience in start-up facility advantageousDemonstrated ability to independently manage projects/work to schedule/deadlinesStatistics experience (including Proactive Process Analysis and Continuous Process Verification)Experience in deviation management and/or change control and/or equipment support and/or equipment qualification, and/or project management.
Contact
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up-to-date CV to paul.wheatley@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering, Information Technology, and Science
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Automation Machinery Manufacturing
Dundalk, County Louth, Ireland
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