Compliance & Validation Specialist

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 early 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 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 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 17th 2025 but we are applying ongoing selection so do not hesitate to send us your application Our Global IS IT team is primarily based in Malmo but we also welcome applicants located near our other sites in Strasbourg Braine or Ambernath provided you are within commuting distance For more information please contact Krister Svard at krister svard polypeptide com Swedish applicants are welcome to contact the local union chairman for Akademikerforeningen or Unionen at 46 040-36 62 00 for support