Compliance & Validation Specialist

Compliance & Validation Specialist Apply here 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 [email protected]. Swedish applicants are welcome to contact the local union chairman for Akademikerföreningen or Unionen at +46 040-36 62 00 for support. Locations Malmö Remote status Hybrid Malmö Our Core Values INNOVATION - We are curious and explore new ways. - We are also ambitious and find solutions. EXCELLENCE - We have a strong technical knowledge, and we deliver results - We lead quality in everything we do - We are adaptable and customer focused TRUST - We believe in teamwork and collaboration. - We lead by example and accept responsibility - We are transparent and we show integrity. About PolyPeptide Group PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a focused 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 offers products and services from pre-clinical through to commercial stages, including generics. Its active custom projects pipeline reflects the opportunities from novel drug therapies in development to fight both widespread and rare diseases. Dating back to 1952, PolyPeptide today runs a global network of six cGMP-certified facilities in Europe, the U.S. and India. PolyPeptide Group AG’s shares (SIX: PPGN) are listed on SIX Swiss Exchange. Founded in 1996 Co-workers Around 1'500