Maintenance & Validation Specialist

About the Job

Pharmacosmos is seeking a skilled Maintenance & Validation Engineer to join their team. As a key member of the technical department, you will be responsible for ensuring the highest standards of validation, documentation, and quality across the organization.

Key Responsibilities

• Define and implement a new Computerized Maintenance Management System (CMMS) and identify user requirements and develop implementation plans in collaboration with internal stakeholders.
• Collect and implement data and optimize maintenance and operational activities.
• Provide training and support to colleagues in the use of CMMS and ensure compliance with regulatory requirements and internal guidelines to maintain a high GMP level in documentation across the technical department.
• Manage change cases and update Standard Operation Procedures (SOP) to ensure compliance.
• Develop and maintain procedures to document departmental activities and maintain traceability.
• Develop a validation strategy for renovations and purchases of new equipment and serve as a sparring partner for the technical department, production, QA, and QC.
• Prepare validation documentation in connection with maintenance of existing equipment, installation of new equipment, or major renovations, including validation plans, protocols, reports, and other relevant documents in accordance with the company's quality standards and regulatory requirements.

Requirements

• A relevant educational background and solid knowledge of technical support, compliance, and procedure updates within the pharmaceutical industry or similar.
• Experience with developing and maintaining electronic systems and handling GMP change cases.
• Deep knowledge of qualification and validation requirements for technical equipment and regulatory requirements and standards within pharmaceutical production, including GMP.

About Pharmacosmos

Pharmacosmos is a leading international healthcare company with nearly 60 years of expertise in iron- and carbohydrate-based treatments for both humans and animals. With a focus on addressing anemia, the company operates in key areas, including the Nordics, Germany, the UK, Ireland, China, and the US, and markets products in over 80 countries. Pharmacosmos has its headquarters in Holbæk, Denmark, where they employ around 210 full-time employees, as well as around 390 full-time employees at subsidiaries around the world. Learn more here: #J-18808-Ljbffr