Germer International - Pharmaceutical Recruiting
Senior Equipment Engineer
Germer International - Pharmaceutical Recruiting, Boston, Massachusetts, us, 02298
Our client, alongside an established pharmaceutical company in the Greater Boston area, is looking to add a Senior Equipment Engineer to their team. This validation/calibration and chromatography SME will oversee calibration and validation processes in GxP and ISO 17025 environments while also serving as a technical escalation point for chromatography systems, including GC, IC, SFC, LC, and LC/MS/MS.
Responsibilities
Design, author, and execute validation protocols (IQ/OQ/PQ) for new or modified equipment, processes, and test methods
Maintain accurate validation and calibration records to support audits and ISO accreditation
Perform planned maintenance, repair, and verification services across multi-vendor laboratory instruments
Train and mentor staff on calibration procedures, ISO 17025 compliance, and validation best practices
Act as SME for chromatography and analytical systems (LC, GC, IC, SFC, LC/MS, GC/MS, and related platforms)
Develop and implement SOPs for equipment qualification and generate qualification reports
Perform on-site and remote service support, planned maintenance, and hardware/software installations
Communicate directly with customers to ensure service quality, provide preventive maintenance guidance, and resolve escalated issues
Collaborate with Quality, R&D, and Service teams to resolve technical issues and support new product/service integration
Participate in internal and external audits to maintain accreditation and regulatory compliance
Required Education & Experience
Bachelor’s degree in Engineering, Chemistry, Biochemistry, Physics, or related scientific discipline
5+ years of experience with life science laboratory equipment in regulated environments (ISO 17025 and GxP)
5+ years of technical experience with chromatography systems (LC, LC/MS, GC, GC/MS, IC, SFC, etc.)
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Engineering, Customer Service, and Quality Assurance
Industries Pharmaceutical Manufacturing and Biotechnology Research
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Responsibilities
Design, author, and execute validation protocols (IQ/OQ/PQ) for new or modified equipment, processes, and test methods
Maintain accurate validation and calibration records to support audits and ISO accreditation
Perform planned maintenance, repair, and verification services across multi-vendor laboratory instruments
Train and mentor staff on calibration procedures, ISO 17025 compliance, and validation best practices
Act as SME for chromatography and analytical systems (LC, GC, IC, SFC, LC/MS, GC/MS, and related platforms)
Develop and implement SOPs for equipment qualification and generate qualification reports
Perform on-site and remote service support, planned maintenance, and hardware/software installations
Communicate directly with customers to ensure service quality, provide preventive maintenance guidance, and resolve escalated issues
Collaborate with Quality, R&D, and Service teams to resolve technical issues and support new product/service integration
Participate in internal and external audits to maintain accreditation and regulatory compliance
Required Education & Experience
Bachelor’s degree in Engineering, Chemistry, Biochemistry, Physics, or related scientific discipline
5+ years of experience with life science laboratory equipment in regulated environments (ISO 17025 and GxP)
5+ years of technical experience with chromatography systems (LC, LC/MS, GC, GC/MS, IC, SFC, etc.)
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Engineering, Customer Service, and Quality Assurance
Industries Pharmaceutical Manufacturing and Biotechnology Research
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