SAP Test & Release Manager

PolyPeptide is on a transformative growth journey – expanding globally, investing in new technologies, and increasing our production capacity through major site expansions and strategic projects. As part of this, we are launching a global SAP S/4HANA implementation and building a new ERP function from the ground up. This is a rare opportunity to join from the beginning and contribute to the implementation and long-term support of a modern, scalable ERP system. We are now looking for an SAP Solution Specialist to join our Global IS/IT organization and play a central role in supporting the SAP platform’s reliability, integration, and compliance – from implementation through stabilization and future enhancements. About us PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange. Our Values Trust: We build and maintain trust in all our relationships – both with each other and with our customers. We support each other and work as a team. Innovation: We are curious and driven by finding smart solutions to the challenges we face. Excellence: We always strive to deliver high quality and adapt to meet the needs of our customers. About the Role As the SAP Solution Specialist, you’ll be a vital part of our ERP team - bridging business functions, internal experts, and external partners. You will work closely with ERP Solution Managers and the ERP Solution Architect to support technical needs across the ERP landscape. This is a collaborative and technically focused role where you’ll combine deep SAP platform knowledge with the ability to troubleshoot, optimize, and contribute to the continuous improvement of our new global SAP S/4HANA environment – particularly across output management, integrations, platform reliability, and compliance. You’ll also play a key role in ensuring operational continuity and supporting validation, change control, and documentation activities during and after the ERP implementation. Key Responsibilities * Provide technical support and advanced troubleshooting within SAP S/4HANA, including integrations, output management, batch jobs, and custom developments. * Act as key technical partner to ERP Solution Managers across modules (Finance, Sales, Supply Chain, Manufacturing, etc.). * Oversee system performance and platform reliability – from day-to-day support to long-term improvements. * Take ownership of output management (e.g., SAP Output Management, NiceLabel) – including user requirements, documentation, testing, and deployment. * Coordinate with infrastructure and print teams on cross-functional technical deliverables. * Support validation, qualification, and compliance processes (e.g. GxP, 21 CFR Part 11, EU Annex 11). * Participate in CAB meetings, change control, and ticket resolution (incidents, problems, service requests). * Manage documentation for technical specifications, functional descriptions, SOPs, and user training. * Monitor license usage, system maintenance, and vendor coordination. * Support roadmap development, lifecycle planning, and communication of system changes to key stakeholders. Your Profile We are looking for a technically strong and business-oriented specialist who thrives in a dynamic and regulated environment: * A Master’s degree in Computer Science, Information Systems, Engineering, or a related field. * 5+ years of experience in SAP, including at least 3 years working with SAP S/4HANA platform and technical solution support. * Experience with E2E Output Management and SAP integrations. * Experience from the pharma/CDMO industry is an advantage. * Good understanding of ERP-related compliance requirements (GxP, validation, documentation, change control). * Strong communication and stakeholder management skills. * Proactive and collaborative mindset – with attention to detail and continuous improvement * Proficient in English, both speaking and writing. FIND THIS INTERESTING? APPLY NOW! Are you ready to take the next step in your career? The position will be open until August 31th, but we are applying an ongoing selection, so do not hesitate to send us your application. Due to summer vacation we will start going through the applications later in August. For more information, please contact Henrik Werdelin at henrik.werdelin@polypeptide.com. You are welcome to contact the local union chairman for Akademikerföreningen or Unionen at +46 040-36 62 00 for support.

PolyPeptide is on a transformative growth journey – expanding globally, investing in new technologies, and increasing our production capacity through major site expansions and strategic projects. As part of this journey, we are launching a global SAP S/4HANA implementation and building a new ERP function from the ground up. We’re looking for an experienced IS/IT Compliance & Validation Specialist to help ensure that our new enterprise systems – especially the ERP platform – are implemented and maintained in line with industry standards, regulatory requirements, and best practices. This is a unique opportunity to join in the ERP journey and take a central role in securing validation of a modern, global ERP system in close collaboration with Global QA. About us PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange. United by Purpose At PolyPeptide, we take pride in contributing to medicines that make a real difference to people's lives and health. Here, you will become part of work that truly matters, every single day. We are driven by our core values: trust, innovation and excellence. This is reflected in how we collaborate, solve problems, and uphold our responsibility for quality and safety for the patients ultimately affected by our work. We are a company undergoing rapid development. Our growth brings a fast-paced environment, change and new opportunities for both employees and the business. Here, you will grow together with us. If you are looking for a workplace where purpose, community and development go hand in hand, then PolyPeptide is the right place for you. About the Role In this role, you will be part of our global IS/IT organization and act as a key resource in securing regulatory compliance across enterprise systems – with a primary focus on the new ERP program. You’ll be responsible for system validation (CSV), audit readiness, change control, and risk management, with a strong emphasis on maintaining compliance with GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5. You will work closely with Global QA, IT, regulatory affairs, and external vendors to ensure that the new ERP platform and other digital systems are inspection-ready, properly documented, and aligned with pharmaceutical regulations and expectations. Key Responsibilities * Develop and execute validation strategies for GxP-relevant systems in accordance with GAMP 5 and biotech/pharma industry standards. * Author and review validation documentation such as validation plans, IQ/OQ/PQ protocols, traceability matrices, and summary reports. * Ensure systems comply with electronic records and signature regulations (21 CFR Part 11, Annex 11). * Perform risk assessments for new systems, upgrades, and system changes, and integrate validation into the change management process. * Maintain audit-ready documentation and support both internal and external audits, including regulatory inspections. * Address audit findings and contribute to corrective and preventive actions (CAPAs). * Collaborate with QA, regulatory, manufacturing, and IT stakeholders as well as external vendors to align on compliance and validation requirements. * Provide training and guidance on validation procedures, regulatory expectations, and documentation standards. Your Profile We are looking for a structured and proactive specialist who thrives in a regulated environment and enjoys collaborating across functions. You bring: * A Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science, or similar. * 5+ years of experience in IT compliance, system validation, or QA in biotech, pharma, or another regulated industry. * Solid knowledge of GxP, GAMP 5, 21 CFR Part 11, and EU Annex 11. * Experience with computerized system validation (CSV) and quality documentation. * Familiarity with enterprise platforms like ERP, MES, LIMS, or QMS. * Excellent analytical, documentation, and communication skills. * Full professional proficiency in English. As a person, you are detail-oriented and accountable – and you take pride in building systems and documentation that stand up to inspection and support safe, efficient operations. FIND THIS INTERESTING? APPLY NOW! Are you ready to take the next step in your career? The position will be open until August 31 but we are applying ongoing selection so do not hesitate to send us your application. Due to summer vacation we will start going through the applications later in August. For more information, please contact Krister Svärd at krister.svard@polypeptide.com. Swedish applicants are welcome to contact the local union chairman for Akademikerföreningen or Unionen at +46 040-36 62 00 for support.