Bachem

Quality Control

• Maintain and perform daily operations in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects
• Write and work with other QC Staff and other Department in the creation and approval of control documents such as specifications, SOPs, STMs, etc.
• Maintain and perform regular verification of the QC equipment for GMP compliance regularly in coordination with QC Director / Supervisor
• Implement and maintain GMP procedures such as following SOP’s, Standard Testing Procedures (STP’s), written procedure and maintaining proper documentation as necessary for Quality Control
• Test, review, and release raw material used in the manufacturing facility for GMP.
• Performing analytical analysis and reviewing data for completeness and accuracy
• Receive, test and release final product peptide manufactured at Bachem
• Test and release in-process control samples used in the manufacturing facility for GMP.
• Performing analytical analysis and reviewing data for completeness and accuracy
• Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work
• Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy
• Write standard operating procedures, standard test procedures and other related GMP documentation
• Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
• Perform QC analysis to include: HPLC, UPLC, Water, Mass Spec, UV, GC, melting point, Optical Rotation, TLC and misc. wet chemistry lab work and other related analytical equipment used for control quality of the GMP facility.
• This work may include calibration and validation of these methods
• Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing and QC release
• Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor
• Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility
• Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals
• Support validation, and stability as necessary to include but not limited to analytical work, documentation and quality GMP procedure

Quality Control Scientist I/II

Financial Planning and Analysis

• Serve as Finance Business Partner for assigned areas
• Capex Investment planning and controlling.
• Monitoring and controlling project progress regarding schedule, resources, and costs of the assigned investment projects.
• Regular updates on project status for key stakeholders, including executives and project team members.
• Prepare financial analyses, KPIs, reports, and presentations for assigned areas: Monitoring spending, labor tracking, and production scrap; Total non-quality cost associated with producing and fixing defective products or services; Productivity, Cycle Counts, Inventory
• Serve as point of contact for all financial matters in the assigned areas
• Regularly conduct cost and variance analyses, including initiating corrective actions
• Reporting and creating ad-hoc analyses for the business
• Serve as liaison for labor time tracking application(s)

Financial Planning Analyst

Manager

• Develop, maintain, and continuously improve short-, mid-, and long-term demand forecasts based on market trends, historical data, and business intelligence
• Lead the monthly Demand Review process of your assigned product group as part of the S&OP cycle.
• Analyze forecast accuracy and deviations and implement corrective actions
• Collaborate with Sales, Project Management and Supply Planning to align on demand change
• Utilize forecasting tools and ERP systems (SAP/IBP) for data analysis and forecast generation
• Prepare reports and KPI analyses to support decision-making

Demand Manager

QA Automation Engineer

• Responsible for Installation and qualification of automation systems for batch processing tanks, solvent recovery system, filter dryers, HPLCs, filtration system, Lyophilizers, ultra-low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and wastewater system
• Collaborate with production and controls team to develop and streamline production process in automating the new and existing system by harmonizing and leveraging technology developed by Center of Excellence
• Develop and train cross-functional team members on utilization and maintaining new automation systems for equipment and system
• Troubleshoot and monitor automation systems and trends to ensure that equipment works to its specifications and appropriate capacities
• Support engineering team and coordinates engineering activities to design, develop, and execute the automation part of strategic investment projects

Senior Automation Engineer

Research Scientist

• Responsible for planning, analyzing and interpreting experiments, and presenting the obtained results
• Planning and timely execution of development activities and process optimizations in cooperation with other departments, taking quality, cost-effectiveness and safety into account
• Performing process transfers (scale-up) and supporting production in the implementation of new processes, partly under cGMP guidelines
• Focus on the LPPS/TAPS area (organic chemistry in solution, peptide couplings, protecting-group chemistry, extraction, precipitation, crystallization)
• Writing reports and preparing presentations on the carried-out work for internal and external customers
• Supporting production in resolving chemical challenges (troubleshooting)
• Active participation in the continuous improvement of our equipment and workflows as well as maintenance of laboratory infrastructure

Scientist, Peptide Drug Substances R&D

Engineer

• Support cleaning validation activities for API and PMO manufacturing
• Monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols
• Conduct related investigations
• Train, coach and mentor team members

Validation Engineer

• Finance Business Partner for assigned areas (local / global)
• Perform regular inventory reconciliations between physical counts and system records.
• Investigate and resolve inventory discrepancies and variances.
• Establish and enforce internal controls around inventory handling and reporting.
• Oversee cycle counts and annual physical inventory processes.
• Prepare financial analyses, KPIs, reports, and presentations for management including: Financial information for monthly reports; Spending, labor tracking, and production scrap; Total non-quality cost associated with producing and fixing defective products or services
• Act as point of contact for all financial matters in the assigned areas
• Conduct regular cost and variance analyses, including initiating corrective actions
• Create reports and ad-hoc analyses for the business
• Act as liaison for labor time tracking application(s)
• Develop and monitor project budgets, creating regular cash forecasts, ensuring financial compliance

Financial Planning Analyst I

• Design, implement, and continuously improve scalable SAP S/4HANA solutions supporting manufacturing and supply chain processes
• Enable and optimize end-to-end business processes across production, supply chain, and quality in GMP-regulated environments
• Architect and implement cross-system integration across SAP and adjacent platforms (MES, LIMS, shopfloor automation)
• Drive digital innovation by delivering data-driven, highly automated processes
• Establish and maintain full regulatory compliance (GxP, CFR Part 11, Annex 11, ISO 27001)
• Engage senior stakeholders across manufacturing, quality, supply chain and IT; translate business needs into architectural solutions

SAP Solution Lead, Implementation

• Manage QMS system enhancement projects and collaborate locally and globally with the continuous improvement, maintenance, and oversight of the Quality Systems.
• Assist with Improving metrics/calculations and issuing reports to assess the health of Bachem US quality system including Global level reporting and assessment.
• Process mapping, Draft, and review of GMP documentation e.g. SOPs, protocols, reports
• Resolve problems with GMP electronic systems and provide guidance on EQMS topics, providing hands-on support for local sites for the effective and lean implementation of these GMP processes and concepts
• Collaborate with QA team members and with other departments to implement improved QMS processes, systems quality culture and documentation landscape.
• Support GMP audits for internal operations, GMP compliance improvements and provide GMP compliance guidance to other departments and BAM Sites as needed.

QMS Process Engineer

• Design, implementation and maintenance of the Digital Manufacturing & Data Lab infrastructure, including automation systems, virtualized environments and network configurations
• Development, configuration and support of Siemens PCS7 systems (including WinCC, Simatic Batch) for laboratory and pilot environments
• Build and maintain simulation capabilities and digital twins using SIMIT to enable virtual commissioning, testing and training scenarios
• Administer and operate the lab’s IT/OT infrastructure, including virtualization, systems and network components
• Integrate controllers, field devices and laboratory equipment into cohesive automation and data environments
• Provide and maintain internal tools, templates and automation libraries for lab users
• Support users (engineers, data scientists) in using lab systems for experiments, testing and troubleshooting
• Participate in automation and digitization projects from requirements management through prototyping and implementation
• Maintain system documentation, ensure configuration management and support testing activities where applicable
• Identify improvement opportunities for the lab environment and introduce new technologies and best practices

Automation Engineer – Digital Manufacturing, Data Lab

QA Engineer

• Provide proactive quality presence on the shopfloor to ensure uninterrupted, compliant manufacturing operations and meeting adherence to schedule
• Act as the primary QA point of contact for production teams enabling fast, informed decision-making and real-time issue resolution
• Ensure seamless QA support by coordinating across QA functions to deliver consistent, and efficient quality support to manufacturing and support preparing quality rated answers for customer requests
• Enforce strict adherence to internal procedures and GxP requirements supporting right-first-time execution and minimizing delays
• Support investigations into deviations and non-conformances, ensuring robust root cause analysis, effective CAPA implementation, and timely closure
• Accelerate by facilitating rapid assessments and ensuring high-quality documentation of quality-related matters
• Represent QA in daily and weekly shop floor meetings, addressing quality risks and promoting a solutions-oriented mindset
• Lead and contribute to continuous improvement initiatives that enhance quality performance, reduce waste, and increase operational efficiency
• Foster a culture of ownership and accountability on the shopfloor, where quality, accountability, and continuous improvement is seen as an enabler

QA Shopfloor Manager

• You are a technical expert (SME) for process automation (DSP) within a major CAPEX project (> CHF 100 million)
• Design, develop, and implement automation solutions (Level 0–2.5) for downstream unit operations: Chromatography, Filtration (UF/DF, TFF), Purification processes
• Translate process requirements into automation concepts, batch logic and control strategies
• Review and optimize automation designs and system architectures in collaboration with external partners
• Integrate systems into the overall automation landscape (DCS, PLC, MES, Historian)
• Ensure compliance with GMP, GAMP5, data integrity and validation requirements
• Coordinate and lead external engineering firms, system integrators and contractors
• Collaborate closely with Engineering, MSAT, IT/OT, and Quality
• Support the project from concept phase through commissioning, qualification, and handover
• Contribute to standardization and development of automation concepts for the new site
• Ensure delivery in terms of quality, budget, and timeline

Senior Process Automation Engineer, DSP

• Act as Subject Matter Expert (SME) for Building Automation / BMS within a major CAPEX project (> CHF 100M)
• Lead the design, specification and implementation of building automation systems, including: HVAC and utility controls (e.g. cooling system and chiller, compressed air), Fire protection and Evacuation System, Access Control & Attendance Time Recording, Gas Detection System, CCTV & Intrusion detection
• Define and review automation concepts, system architectures and interfaces (e.g. BMS ↔ PCS / PLC / SCADA / IT systems)
• Ensure seamless integration of BMS into the overall plant automation landscape
• Develop and review key lifecycle documents: URS / FS / DS Automation and data integrity concepts, Commissioning and qualification strategies
• Ensure compliance with GMP, GAMP5, Annex 1/11, 21 CFR Part 11 and data integrity requirements
• Lead and coordinate external engineering companies, system integrators and vendors
• Oversee commissioning, qualification (CQV) and validation activities
• Collaborate closely with Engineering, Operations, IT/OT, CSV and Quality functions
• Support standardization and development of BMS concepts for the new site
• Drive troubleshooting, performance optimization and digitalization initiatives
• Ensure adherence to project timelines, quality and budget targets

Senior Building Automation Engineer – Large CAPEX Pharma Project

• Develop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports
• Perform, coordinate, execute and analyze cleaning recovery studies
• Lead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables
• Train, coach and mentor team members
• Plan and perform required periodic re-validation / re-qualification activities