Responsibilities

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.