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Technical Operations Engineer

Job Title: Technical Operations Engineer
Location: Cork
REF: 91979
Job Published: 9 months ago

Job Description

Contact: Caroline Kingston
Telephone: 0868395531

Technical Operations Engineer
Our client, a medical device company in Cork are currently looking to recruit a Technical Operations Engineer for their site.

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 will report solid line to the TO Director
  • The Technical Operations Engineer is a key contributor to LCM and process improvement initiatives on the site.
Main Duties & Responsibilities
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 siteTO 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 lifecycle 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
  • 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
  • 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 0868395531 /
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