Customer Support Engineer - Chromatography
Company
PerkinElmer
Location
Remote
Type
Full Time
Job Description
When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.
Job TitleCustomer Support Engineer - Chromatography
Location(s)Waterford, Ireland
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.
Date Posted
11/22/2024
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