Senior Tech Transfer Engineer (Drug Substance)

Posted 14 February 2025
Salary Competitive
LocationIreland
Job type Contract
DisciplineLife Science Recruitment
ReferenceCR/076084
Contact NameNicole Elphick

Job description

Orion Group Life Sciences are currently recruiting a Senior Tech Transfer Engineer (Drug Substance) on behalf of our Multinational Biopharmaceutical client on an initial 11-month contract (with potential to extend). Fully remote role. 


Our engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
The External Manufacturing (ExM) Technical Operation organization is seeking a highly motivated individual for a Technical Transfer position. ExM Tech Ops is accountable for technology transfers and commercial production of Biological Drug Substance at our External Partners (EPs).  This person will have the opportunity to participate in all these areas. This may include supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and providing support for process and capacity optimization.

Responsibilities include:
  • Work with External Partners to achieve business goals and to establish a common culture that benefits our company, External Partners, and patients.
  • Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
  • Responsible for technical 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 at External Partner 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, Quality, and External Partners.
  • Ensure that External Partners are inspected 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.
Education Minimum Requirement:
  • 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 4 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 Maintenance.
  • Travel will be a requirement of this position at approximately 25%
  • Strong communication in English and teamwork skills.
Preferred Experience and Skills:
  • Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer.
  • Demonstrated ability to independently manage projects/work to schedule/deadlines.
  • Statistics experience (including Proactive Process Analysis and Continuous Process Verification).
  • Experience in deviation management and/or change control and/or equipment support, and/or project management.
 
 
 
 
 


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.