Descripción
Are you an experienced validation professional looking to work in a highly regulated and advanced pharmaceutical environment? At Halden Pharma, we are strengthening our QC Validation and Compliance team and are now looking for a Senior Validation Engineer / Specialist to play a key role in ensuring quality, compliance, and robustness of our analytical methods. This is a unique opportunity to join a specialized pharmaceutical manufacturing company where you will work closely with experts across QC, QA and production - and contribute directly to delivering medicines to patients. About the role: In this position, you will support the team within analytical method validation and play a central role in method transfers, implementation, and lifecycle management. You will work in a dynamic environment with a high level of cross-functional collaboration and exposure to both internal stakeholders and external partners. Key responsibilities: Lead method transfer, validation, verification and implementation within the QC Chemistry Laboratory Author, review and approve analytical methods and related documentation Collaborate with external laboratories, including contract setup and approval of transfer protocols and reports Prepare and approve key quality documentation (SOPs, protocols, reports, risk assessments, specifications) Ensure timely implementation of pharmacopeia updates and verification of compendial methods Support organization within analytical validation field providing scientific and regulatory expertise Execute change control, handle deviations and drive CAPA processes in line with the Quality Management System Represent the department in audits and interactions with customers and regulatory authorities Who we are looking for: We are looking for someone who combines strong technical expertise with a pragmatic and collaborative mindset. Qualifications: Bachelor's or master's degree (or equivalent) in Chemistry, Pharmacy, Biotechnology, Microbiology or another rela