Position: QC Instrumentation Analyst
Location: Swords, Co. Dublin
Contract: 12-Month Fixed Term
About Us
SK pharmteco is a global Contract Development and Manufacturing Organization (CDMO) with state-of-the-art facilities in Korea, the US, France, and Ireland.
We are part of SK Inc., a Korean company with revenues of $99 billion in 2023.
Our mission is to produce and deliver life-changing therapies that improve patient outcomes and save lives.
The SK pharmteco Small Molecule, Europe facility located in Swords, Co. Dublin, has been a leader for over 60 years in the development, scale-up, and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates.
With our talented workforce, advanced technical capabilities, and top-class facilities, we have helped produce some of the world’s most important medicines — and continue to do so today.
Learn more: www.skpharmteco.com
Current Opportunity
We are seeking to recruit a QC Instrumentation Analyst for a 12-month contract to join our Instrumentation Group within the QC Department.
Reporting to: QC Team Lead
The successful candidate will be responsible for managing and controlling the laboratory instrumentation calibration program as well as handling unplanned maintenance activities.
Key Responsibilities
- Coordinate the calibration schedule in collaboration with vendors (e.g., Agilent).
- Review calibration and qualification documentation for all laboratory instruments.
- Review reports related to unplanned maintenance and corrective actions.
- Manage changes to instruments, including relocations and decommissioning.
- Troubleshoot laboratory equipment and resolve technical issues.
- Oversee the purchase and qualification of new laboratory instruments.
- Manage instrument change controls to maintain compliance.
- Develop new SOPs and ensure all equipment-related procedures are up to date.
- Lead calibration investigations and implement improvements.
- Support the implementation, qualification, and routine maintenance of analytical instruments.
- Ensure GMP compliance in all QC operations and documentation.
- Manage relationships with suppliers, including new equipment and software solutions.
- Foster a culture of growth, enablement, and high performance within the team.
Requirements
- Bachelor’s degree in Analytical Science, Chemistry, or a related field.
- Minimum of 3 years of experience in the pharmaceutical industry.
- Strong understanding of Quality Control operations.
- Experience participating in regulatory audits with knowledge of FDA regulations, GMP standards, and their application to API manufacturing.
- Knowledge of equipment validation and change control procedures (desirable).
- Strong organizational and time management skills to manage multiple tasks, prioritize workloads, and meet deadlines for calibrations, maintenance, and testing.
- Ability to interact effectively with Quality Assurance (QA), Instrumentation Management (IM), and multiple vendors.
- Highly motivated team player with proven success in collaborative environments.