PerkinElmer are seeking a Senior Service 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.
* Experience in Service with most common Manufacturers.
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:
* Ability to ramp up the technical skills of the team and act as engineer team lead.
* 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.
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