Bachem

Engineer

• Develop strategy, establish acceptance criteria, and generate and execute cleaning validation protocols and reports
• Perform, coordinate, execute, and analyze cleaning recovery studies
• Lead cross-functional project teams to address issues and ensure timely completion of qualification and validation deliverables
• Provide qualification and validation guidance and strategy during project planning and development phases
• Train, coach, and mentor Quality Engineer I and II
• Write validation protocols and final reports, test methods, standard operating procedures, and technical reports
• Plan, write, and execute DQ, IQ, OQ, and PQ qualification protocols and reports
• Independently conduct and document investigations related to validation studies
• Evaluate validation studies and recommend improvements to operations, processes, and methods
• Ensure the accuracy and validity of testing results
• Support and assist with inspections and audits
• Plan and perform periodic re-validation and re-qualification activities
• Communicate with associates across the company to ensure timely completion of tasks and projects
• Adhere to cGMP and safety procedures and contribute to GMP systems improvements
• Perform other related duties as assigned

Senior Validation Engineer

Quality Control

• Receive, log, label, route, and track raw material, in-process, stability, and finished-product samples and associated documentation
• Maintain QC sample records, stability schedules, trackers, dashboards, and controlled laboratory data; enter and trend/graph data
• Archive, retrieve, organize, and reconcile analytical documentation and laboratory records
• Coordinate external testing, including sample preparation, shipment documentation, status follow-up, and filing of results
• Manage reference materials, standards, reagents, retained samples, and laboratory consumables, including inventory monitoring and ordering support
• Support peptide and material disposition activities by compiling records, performing approved calculations, and routing documentation for review
• Support generation, revision, review routing, and maintenance of QC documentation, including SOPs, forms, training records, deviations, change controls, and out-of-specification documentation
• Coordinate sampling and testing activities with Quality Control, Quality Assurance, Production, and other departments; communicate status and potential issues
• Maintain assigned QC equipment and work areas; assist with equipment records, service coordination, and calibration status tracking
• Support special projects, regulatory or customer requests, and continuous-improvement activities, including QC dashboard development

Quality Control Technician

• Lead C&Q activities within multidisciplinary large capital projects
• Coordinate and manage C&Q-related deviations and changes within defined timelines and quality standards
• Manage budget, schedule, prioritization, resources, and quality of C&Q execution
• Analyze options, plan execution strategies, and develop detailed C&Q schedules
• Prepare tender documents, support procurement processes, and estimate costs
• Ensure smooth handover to Operations and Quality
• Manage risks and derive proactive measures for deviations
• Manage and onboard C&Q teams, including external partners
• Train C&Q teams and ensure adherence to internal standards
• Communicate clearly and appropriately with stakeholders
• Collaborate with global sites to harmonize C&Q standards and digital processes
• Support supplier evaluation and coach local SMEs
• Promote lean and agile methods in engineering and C&Q
• Perform technical reviews in CAPEX projects
• Participate in or lead international GMP engineering, C&Q, and global initiative teams

Senior Commissioning & Qualification Engineer

System Administrator

• Administer, configure, and maintain the LIMS platform, including upgrades, troubleshooting, and performance optimization
• Collaborate with QC analysts, IT, and QA to ensure LIMS and associated systems comply with GxP, GMP, and FDA regulations
• Configure and manage master data, workflows, and user accounts within LIMS
• Support laboratory staff with LIMS- and instrument-software-related issues; provide training and guidance to end users
• Integrate LIMS with laboratory instrumentation and QC software such as Chromeleon and Empower
• Develop, review, and maintain documentation, including URS, OQ, PQ, SOPs, policies, and protocols
• Participate in system validation, change control, and audit readiness activities
• Create and manage reporting formats, queries, and data analysis tools using SQL and custom reports
• Conduct periodic audits and reviews to identify issues, ensure compliance, and recommend improvements
• Monitor equipment/software performance, coordinate calibrations and preventive maintenance, and support resolution of system-related issues
• Benchmark best practices, identify trends, and contribute to continuous improvement of laboratory data management systems

Quality Control System Administrator

Artificial Intelligence

• Test M365 Copilot functionality and newly released features
• Analyze adoption, usage patterns, and optimization potential
• Support the configuration of M365 Copilot
• Take over user enablement from the external partner after the project ends
• Refine use cases with business departments and gather requirements
• Technically implement use cases, including system integration via Model Context Protocol (MCP)
• Build internal Copilot Studio expertise
• Document use cases and platform configurations in Confluence

Senior Validation Engineer

Quality Control Technician

Senior Commissioning & Qualification Engineer

Quality Control System Administrator

Productivity AI Internship – Temporary