Technical Operations Engineer, Pharmaceuticals, Senior Validation Engineer, People Management
Here at Hays Recruitment Ireland we are currently recruiting for a Technical Operations Engineer for our client a major multinational Pharmaceutical, Biotechnology and Medical Devices manufacturer based in Ringaskiddy, Cork.
The Technical Operations Engineer is a member of the Technical Operations (TO) Team and a key contributor to process improvement initiatives. In addition, they should have a keen aptitude for implementing and maintaining standards and driving efficiency within the business while supporting introduction and validation of new and existing products. The Technical Operations Engineer provides technical support for processes by providing facilitation / technical expertise.
* Manage / execute the validation and cleaning program for new and existing products
* Issue / review validation plan, protocols and reports
* Be the site TO representative in Cluster/NPI project teams as process / validation SME
* Strong analytical and Problem Solving skills
* 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
* Lead / support process improvement projects, including new technology / analytics introduction (e.g. MVA, PAT)
* Contribute to Standardization initiatives for Technical Operations
* Technical support / direct participation in partnership with Quality / Operations on any regulatory audits and inspection requirements.
* Conduct and/or participate in problem solving efforts by analysis and correction of both process and equipment problems to maintain or improve existing site operations.
* Represent Technical Operations in engineering projects and coordinate small engineering projects.
* Support the introduction of new processes by coordinating and executing the preparation activities.
* Assist in process and equipment design to support new products and the legacy product portfolio.
* Execute cost reduction and efficiency improvement projects using Process or Design Excellence techniques. Utilises appropriate risk management tools such as FMEA, HAZOP, LOPA and business risk evaluations.
* Conduct training for operations and maintenance personnel.
* Maintain knowledge of cGMPs, process safety practices and environmental standards.
Additional position requirements
* Required to produce high quality and accurate work in a timely manner to meet the production schedule.
* Lead and coordinate multiple projects. Prioritize and work effectively across the organization in completing them on time and in budget.
* Participate in or lead specialized task forces and teams with sister companies, company Supply Chain and the API-Small Molecule Cluster, per policy.
* Follow all company and site policies and procedures and the intent of our Credo.
* Assume responsibility for the safety, environmental, quality, and business effects of personal work and of work performed as a team.
* Successfully complete regulatory and job training requirements
* Other projects or assignments as requested by management.
EDUCATION and/or EXPERIENCE
* Honours degree in Engineering or Science, with minimum 5 years’ experience in a pharmaceutical environment
* Desirable candidate would have Masters Degree, PhD in Chemistry or Equivalent with 5 – 8 years’ experience in a pharmaceutical environment.
* Excellent social and communication skills
* Self-driven and keeps up to date with regulatory, technical developments within the industry.
* Acute attention to detail
* Focus on patients and customers at all times.
* Project management, organizing, planning and coordination skills is preferred.
* Ability to seek innovation and change to ensure competitiveness is preferred.
* Affinity with data analytics tools is preferred.