Waterford Ireland

Responsibilities

Location Waterford, IE Job ID REQ-054133

PerkinElmer are seeking a Customer Support Engineer who will be based on our client site in Waterford Monday - Friday.

Preference will be given to candidates with certification in analytical instrumentation but we would also consider training candidates with previous user experience of HPLC systems.

Requirements:

Education and Experience:

• Bachelor's degree in Chemistry, Chemical Engineering, Analytical Chemistry, or a related field.
• Minimum of 8 years of hands-on experience working with High-Performance Liquid Chromatography (HPLC) in a pharmaceutical or biotechnology setting.
• Deep understanding of chromatographic techniques, including HPLC, UHPLC, and related methods.

Technical Skills:

• Extensive expertise in Preventative Maintenance of HPLC systems, including experience with troubleshooting and component replacement (pumps, detectors, columns, injectors).
• Experience in Validation and Verification activities for HPLC systems to ensure compliance with regulatory requirements.
• Strong background in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of chromatographic systems.
• Proficiency in using chromatography software such as Empower, or similar platforms.
• Ability to optimize chromatographic methods and troubleshoot issues involving poor peak resolution, pressure fluctuations, and column maintenance.
• Knowledge of current Good Manufacturing Practices (cGMP) and adherence to industry standards.

GMP Training and Compliance:

• GMP certification or extensive training with proven experience in working in GMP-compliant environments.
• Thorough understanding of regulatory guidelines, such as FDA, USP, and ICH, as applicable to HPLC method development, validation, and equipment maintenance.

Validation and Documentation:

• Experience with the development, execution, and review of validation protocols and procedures for analytical instruments.
• Ability to write, review, and approve SOPs, equipment calibration records, maintenance logs, and validation reports.
• Proven capability to execute instrument qualification activities and create comprehensive documentation for audits.

Analytical Expertise:

• Strong analytical skills in troubleshooting HPLC systems, including identifying root causes of system failures or performance issues.
• Ability to develop and implement preventative maintenance programs that improve system reliability and performance.
• Experience with risk assessment and mitigation strategies for HPLC equipment maintenance and operation.

Problem-Solving and Continuous Improvement:

• Ability to assess instrument performance trends and take proactive measures to avoid downtime.
• Understanding of Lean, Six Sigma, or other process improvement methodologies to streamline laboratory workflows and maintenance schedules.
• Provide recommendations for system upgrades, spare parts management, and new technology adoption to improve laboratory efficiency.

Communication and Teamwork:

• Strong interpersonal skills to work effectively with cross-functional teams, including R&D, Quality Assurance, and Manufacturing.
• Ability to train laboratory staff on equipment maintenance, GMP compliance, and troubleshooting procedures.
• Excellent written and verbal communication skills for collaborating with internal and external partners and for contributing to regulatory audits.

Audit Readiness:

• Experience supporting internal and external audits, with a focus on instrument qualification, calibration, and maintenance records.
• Familiarity with data integrity principles as they relate to chromatography data systems, ensuring compliance with 21 CFR Part 11.

Safety and Compliance:

• Adherence to safety protocols, proper handling of chemicals, and disposal of waste according to established safety guidelines.
• Knowledge of laboratory best practices to maintain a safe working environment and compliance with company and regulatory standards.

Preferred Qualifications:

• Certification in analytical instrumentation from a recognized vendor (e.g., Agilent, Waters).
• Experience with Waters Alliance, Agilent 1260/1290 systems, or other major HPLC manufacturers.
• Experience with method development and transfer processes within the pharmaceutical industry.
• Familiarity with data automation, remote monitoring of systems, and emerging technologies in chromatography.

Working Conditions:

• Must be willing to work in a laboratory environment, including occasional work outside of regular business hours to address urgent maintenance needs.
• Ability to stand for extended periods, lift equipment components, and perform physical tasks associated with equipment maintenance.

PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.