Senior Instrumentation Chemist

Abbott Laboratories (Tipperary, Ireland) 12 days ago

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Ireland Vascular Division Clonmel

Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.

Our broad line of vascular devices–which includes vessel closure, endovascular and coronary technologies–are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.

We currently have a role for the position of Snr Instrumentation Chemist and this role will involve the following:

PURPOSE OF THE JOB:

  • Ensures that all instrumentation across the Analytical and Microbiology laboratories are maintained in a validated state through management of a PM schedule and ensuring adherence to PM schedule by the Instrument group and contract vendors.
  • Leads troubleshooting and resolution of issues that may arise during laboratory instrument qualification and use.
  • Supports the introduction of new equipment and software to the lab through completion of equipment qualification activities with a focus on Data Integrity principles.
  • Responsible for administration of Laboratory Computerized Systems
  • Responsible for the decommissioning of all equipment as appropriate.
  • Supports equipment related investigations to determine root cause and implement corrective actions and preventative actions.
  • Ensures all equipment activities are in compliance with Abbott procedures and processes.

MAJOR RESPONSIBILITIES:

  • Demonstrate strong technical ability for troubleshooting instrument related issues in Analytical and Microbiology Laboratory equipment (for example- HPLC, UPLC, GC/MS, UV, NIR, FTIR instrumentation) to achieve maximum equipment uptime.
  • Execute all aspects of instrument and equipment validation support throughout the validation lifecycle:
  • New instrument and equipment validation (URS, IQ, OQ, PQ, Summary Reports
  • Periodic review of instrument qualification packages as required
  • Routine lab support with respect to instrument issues
  • Instrument and equipment validation scheduling
  • Administration of Laboratory Computerized Systems.
  • Liaise with Vendors, Calibration, EHS, QA and QC to deliver instrument qualification and re-qualification schedules.
  • Preparation and review of required validation documentation including protocols and reports.
  • Ensure data integrity requirements are included and met as part of the new instrument qualification.
  • Establishment of procedures for management and maintenance of the validated system (data archive, project creation, security etc.).
  • Authoring, review and approval of qualification/validation protocols and reports, status reports, regulatory documents and process descriptions.
  • Completion of periodic reviews and compendial reviews as they relate to maintaining the qualified status of the system
  • Support the lab investigation process by providing accurate and concise information in a timely manner and raising investigations, where required.
  • Participate in cross functional teams as required to provide support on, and resolution of, instrument and equipment validation requirements.
  • Partner closely with customers and stakeholders to understand instrument and equipment validation requirements and escalate when necessary.
  • Proactive engagement with customers and key stakeholders.
  • Maintain Analytical and Microbiology laboratories in a state of audit readiness at all times.
  • Participate in new initiatives such as the 5S, Standard Work and Data Integrity programs as they arise.
  • Participate in and drive the continuous improvement of all aspects of the group.
  • Ensure compliance with cGMP, corporate standards /Abbott’s Quality System/ site policies / procedures, and regulatory requirements.
  • Technical writing assignments including SOPs, trend reports, risk assessments, laboratory investigations, and change controls.

EDUCATION & COMPETENCIES:

  • (Experience/Education) National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 4+ years of related work experience or an equivalent combination of education and work experience.
  • (Technical/Business Knowledge (Job Skills) Comprehensive knowledge of a particular technological field.  Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is a recognized expert in a workgroup and across functions. Will perform this job in a quality system environment.  Failure to adequately perform tasks can result in non-compliance with governmental regulations.
  • (Cognitive Skills) Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business.
  • (Influence/Leadership) Understands the business environment and relates extensive knowledge of internal and external technological activities to trends. Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. Participates in the development of other technical contributors by facilitating training and providing feedback and guidance. May lead a project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.  Exercises judgment independently.
  • (Planning/Organization) Plans and organizes project assignments of substantial variety and complexity.  Initiates or maintains a schedule for projects and project milestones.  Establishes priorities of individual or project assignments.
  • (Decision Making/Impact) Selects methods and techniques to lead a project to completion. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.
  • (Supervision Received) Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.
  • (Supervision Provided) May provide work direction and guidance to exempt and/or skilled non-exempt levels of employees. May be asked to evaluate the performance of and assist in career development planning for subordinates.

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Senior Instrumentation Chemist

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