Engineer Manufacturing Compliance

vor 14 Stunden


Neuenburg, Schweiz Gi Group Vollzeit

Direct message the job poster from Gi Group

For our partner in the Pharmaceutical industry, in the Canton of Neuchâtel,

Gi Life Sciences is looking for an:

Engineer Manufacturing & Compliance

(Temporary contract)

Your mission:

This role will support the Head of Packaging Operations in monitoring quality and performance metrics while acting as a referee for the operational team for GMP systems, documentation, and training.

You will be in charge of authoring, owning and leading updates of GMP documents/projects related to Bulk, Packaging and/or Warehouse operations. Additionally, initiating and owning deviations assessments and participating to investigation tasks as required.

Your responsibilities:

  • Initiate deviations and participate to investigations.
  • Follow up and implement assigned CAPA’s.
  • Author and review manufacturing documents, including specifications, working practices, SOPs, forms and logbooks. Follow up approval flow within electronic documentation system.
  • Lead or support manufacturing projects (new equipment, process change, etc…) by managing the documentation associated with the project (URS, Protocol, Change Control, etc…)
  • Ensure distribution and withdrawal of GMP documents in manufacturing area.
  • Participate or lead technical aspects for specific projects (SAT, FAT, Technical visit at the supplier or on site) to bring technical expertise.
  • Act as quality system and GMP Documentation referee for the Manufacturing Packaging Ops Team and as a key representative for QA Ops.
  • Support the team in proactively monitoring quality, safety and performance / reporting metrics (OEE, Tier Meeting) and in proposing improvement measures.
  • Act as the back-up of other Engineer Manufacturing & Compliance in Bulk and Warehouse departments.
  • Lead risk assessments, data integrity risk assessment and risk management within cross functional teams (from draft to approval).
  • Perform complaint investigations and manage the defect library process and the related training for the site.

Your profile:

  • BS/MS in Engineering/Technical discipline or equivalent experience.
  • 7 years’ experience in pharmaceutical validation, packaging, drug manufacturing process or related field.
  • Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP.
  • Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
  • Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes especially in Oral Solid Dosage form (OSD).
  • Well-developed ability to constructively work across functional areas and levels to achieve results.
  • Strong verbal and written communication skills.
  • Strong analytical, problem solving, influential and deductive skills.
  • Capability to work with short deadlines and simultaneous activities.
  • Excellent organizational and project management skills.
  • Fluent in English and in French.
Seniority level
  • Associate
Employment type
  • Temporary
Job function
  • Science
  • Pharmaceutical Manufacturing
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