Associate Technical Specialist Job

Date: Jul 19, 2019

Location: Cork, IE

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Requisition ID: MAN006685

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.


The Vaccines Operations team are currently recruiting for a Technical Specialist to provide Technical expertise to the manufacturing team. 

 
This role will report to the Technology Lead, Vaccines team.
 

The Technical Specialist will demonstrate a high level of innovation, enthusiasm and drive to deliver technical excellence for characterisation and optimisation of manufacturing processes and will be accountable for providing scientific and technical support to the operations team for effective and efficient running of all operations activities to a defined daily, weekly and monthly schedule as agreed with our customers.

 

This requires a flexible, collaborative, and coaching style and will require a substantial amount of his/her time within the IPT process, engaging and communicating with all IPT members.

Qualifications

  • Provide Technical Support for the commissioning and qualification of the drug substance manufacturing process including equipment IOQ and PQ
  • Support the facility start-up process by leading/participating in work groups to realise successful facility qualification and validation
  • Work with site support groups to deliver qualified raw materials and consumables for the manufacturing process.
  • Support the technology transfer of drug substance manufacturing process through effective collaboration with business partners and customers.
  • Author, review and approve manufacturing documentation associated with transferred processes.
  • Troubleshoot manufacturing issues and lead investigations through scientific problem-solving approaches.
  • Partner with quality groups to support change management for the manufacturing process.
  • Generate study plans, protocols and summary reports to support the manufacturing process.
  • Lead and participate in process validation studies including but not limited to, cleaning studies, mixing studies and process characterisation studies.
  • Establish and lead implementation the continued process verification program to effectively manage product life cycles.
  • Adherence to highest standards for Compliance (Quality and Safety)
  • Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, regulatory inspections and incident investigations.
  • Actively participate in a culture of Continuous Improvement and process optimisation by deploying MSD Six Sigma tools.
  • Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. 


 
Experience
 
General

  • 1-2 years’ experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience

 
Technical

  • Experience in at least two of the following areas protein chemistry, process engineering, cell culture, purification technologies, process operations, statistics, technology transfer, microbiological control of bio-manufacturing processes, cleaning validation, process validation, regulatory inspections.

 
People

  • Evidence of Continuous Professional Development and cross skilling

 
Education

  • BSc Degree in Biochemistry, Microbiology, Chemistry, Engineering or a related field

 
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means. 


Job: Manuf./Operations Generic
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings: 2
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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