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.
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
- 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
- Identify / lead / contribute to process improvement projects, including new technology / analytics introduction (e.g. PAT, MVA)
- Contribute to Standardization initiatives for Technical Operations
- 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
- 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.
- 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
- Drives for innovation and change to ensure competitiveness
- Can-do mentality, agility & flexibility able to work with stretched goals and deadlines
- 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.
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