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Technical Operations Engineer - Contract

Job Title: Technical Operations Engineer - Contract
Contract Type: Contract
Location: Cork
REF: 96378
Job Published: 4 months ago

Job Description

All applicants must have a valid working visa for Ireland for this contract role

Contact: Caroline Kingston
Telephone: 086 8395531

Technical Operations Engineer - Contract
Our client, a pharmaceutical company in Cork are currently looking to recruit a Technical Operations Engineer for their site on a contract basis.

The Technical Operations Engineer is a member of the Technical Operations (TO) Team with the dedicated focus on
  • Continued Process Verification
  • Process Validation
  • Process Improvements
  • Leading complex cross functional investigations
  • Standards and new technology deployment
The Technical Operations Engineer is a key contributor to LCM and process improvement initiatives on the site.
Life Cycle Management
  • Manage / execute the validation program related to LCM for post stage gate 12 products
  • Issue / review validation plan, protocols and reports
  • Be the site TO representative in LCM/NPI project teams as process / validation SME
  • As required coordination of LCM projects on site, under responsibility of global TO organization
Technology & product technical life cycle management
  • Own / participate in the CPV program by issuing plans, protocols and reports and oversee the execution.
  • Lead complex investigations on the site by providing technical expertise
  • Provides process / technology input to SOP’s, Master Batch Records and change controls
  • Partner with Engineering & Maintenance and contribute to equipment changes / introduction projects on the site
Innovation & Standardization
  • Identify / lead / contribute to process improvement projects, including new technology / analytics introduction (e.g. PAT, MVA)
  • Contribute to Standardization initiatives for Technical Operations
  • Inspection Readiness and Execution
  • Technical support / direct participation in partnership with Quality / Operations on any regulatory audits and inspections

Technical Owner
  • The TO engineer can also take the role of an API Technical Owner in consultation with global Technical Operations

Key Competencies Required
Specific knowledge
  • Strong expertise on pharmaceutical manufacturing (Small Molecule API) processes and equipment, specifically for the applicable technology platform
  • Project management (FPX or other) – team member / project lead
  • Process excellence (6sigma), lean concepts and statistical skills
  • Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for Technology Platform.
Personal and interpersonal skills / Leadership skills
  • Ability to lead cross functional team and to manage complexity and change
  • Ability to interact at different levels of the organization, work under pressure, handle conflicting interests
  • Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly
  • Team player with well-developed problem solving skills
Personal attitude and mind-set
  • Drives for innovation and change to ensure competitiveness
  • Can-do mentality, agility & flexibility able to work with stretched goals and deadlines
Qualifications & Experience
Essential: University degree in Engineering or Science, with minimum 5 years’ experience in a pharmaceutical environment
And/or an equivalent combination of education and experience in
  • API Manufacturing and Purification for small/large molecules
  • Quality Assurance and Regulatory
  • Validation
  • Desirable: Master Degree or Equivalent with 5 – 8 years’ experience in a pharmaceutical environment.

For further information on this Technical Operations Engineer role in Cork please contact Caroline Kingston on 086 8395531 /
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