Technical Transfer Engineer

1 month ago

Ireland PSC Biotech Full time
Technical Transfer Engineer (Fill Finish)
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 4-5 years
  • City Cork
  • State/Province Cork
  • Country Ireland
Job Description

About PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Job Title: Technical Transfer Engineer (Fill Finish)

Our engineers help ensure that internal and externalmanufacturing operations remain operational, continuously improve, andinnovate. With our extensive range of facilities and environments, ourEngineers have opportunities across many diverse areas including Biological,Chemical, Automation, Capital Projects, Maintenance, Safety, ProcessDevelopment, Technical Services, Utilities, and Validation.

The External Manufacturing (ExM) Technical Operationorganization is seeking a highly motivated individual for a Technical Transferposition. ExM Tech Ops is accountable for technology transfers and commercialproduction of sterile drug product at our External Partners (EPs).This person will have the opportunity toparticipate in all these areas. This may include supporting the execution oftechnology transfers, providing manufacturing process support to resolve commercialproduction issues, and to provide support for process and capacityoptimization.

Requirements

Responsibilities include:

· Work with External Partners to deliver technicaltransfer of our vaccine and biologics programs.

· Responsible for technical activities for thecommercial manufacturing process at the External Partner, which includesauthorship of change control, management of process improvement projects,statistical analysis of process performance, and investigation of atypicalevents.

· 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 insupport of Commercial and / or Technology Transfer Person-In-Plant Activities.

· Translate understanding of GMP requirements andcurrent regulations and develop standardized work to meet these requirements bypartnering with Operations, Quality, and External Partners.

· Ensure that External Partners are inspectionready for all routine inspections and / or inspections related to new productintroductions or transfers, in concert with Operations, Quality, andRegulatory.

· Responsible for participation in creating,sharing, and adopting best practices and business process strategies.

Required Education, Experience and Skills:

· Minimum of 4 years post-bachelor's degreeexperience in a GMP functional area or support of a GMP functional area, suchas Operations, Technical Operations, Technology, Engineering, and/orMaintenance

· Must have 3-5 years fill finish TechnicalTransfer experience for this role.

· Travel will be a requirement of this position atapproximately 25-40%

· Strong communication and teamwork skills

Preferred Experience and Skills:

· Experience in Fill Finish activities – (Vial /Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.)

· Demonstrated ability to independently manageprojects/work to schedule/deadlines.

· Statistics experience (including ProactiveProcess Analysis and Continuous Process Verification)

· Experience in deviation management and/or changecontrol and/or equipment support, and/or project management.

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