DSP Operations Senior Technician

Highly Competitive
  1. Permanent
  2. Bioprocessing
  3. Iceland
Reykjavík, Iceland
Posting date: 12 Oct 2023
56764

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a DSP Operations Senior Technician to join a pharmaceutical organisation. This role is on a permanent basis and is located in Reykjavik.

Responsibilities:

  • Conduct cGMP actions within Grade CNC, D, and C areas.
  • Offer SME for DSP processing steps as and when needed.
  • Serve as an SME writer/evaluator and/or approver for authored processes, SOPs, BMRs and any other cGMP documentations within spa of knowledge.
  • Assume ownership of deviations, such as guiding and arranging investigations, when necessary, to assist with recognising root cause and suitable corrective actions.
  • Guarantee QMS records are instigated, progressed, and closed within the company's outlined KPIs.
  • Monitor and guarantee manufacturing actions are carried out rendering to cGMP.
  • Train new starters to partake in accomplishing a multi-skilled and engaged DSP team.
  • Get involved in tasks that include any other divisions within the company.
  • Constantly recognising process improvement to aid in producing and preserving a lean, flexible and agile manufacturing facility.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Educated to a degree level in a pertinent field or equivalent work experience.
  • Expertise on downstream purification procedures for production of monoclonal antibodies and recombinant protein therapeutic products.
  • Acquaintance with operating downstream processing equipment.
  • Familiarity with purification practices, scale up, technology transfer and process validation actions.
  • Demonstrable experience within a biopharmaceuticals or technical field would be ideal.
  • Exhibited experience in training others.
  • Past involvement assisting with pre-approval inspections (PAI) and working with global regulatory agencies which involves the FDA and EMA.
  • Knowledge of cGMP compliance and affiliated documentation.

If you are having difficulty in applying or if you have any questions, please Patrick Turbidy on +44 203 530 5120.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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