Mechanical Engineer- Pharma Documentation

Location: Denmark 

Our client is seeking a detail-oriented Mechanical Engineer with experience in pharmaceutical documentation to join their team. The ideal candidate will have a strong background in mechanical engineering principles and hands-on experience in documenting mechanical systems and processes within a pharmaceutical manufacturing environment.

• Responsibilities:
  Documentation Management: Develop, maintain, and update comprehensive documentation for mechanical systems, equipment, and processes used in pharmaceutical manufacturing, including specifications, drawings, manuals, and standard operating procedures (SOPs).
• Change Control: Manage the change control process for mechanical documentation, ensuring that all changes are properly documented, reviewed, and approved according to company procedures and regulatory requirements.
• Compliance Assurance: Ensure that all mechanical documentation meets regulatory standards, including FDA regulations, cGMP guidelines, and industry best practices.
• Quality Assurance: Collaborate with quality assurance teams to conduct reviews and audits of mechanical documentation, identifying and addressing any discrepancies, gaps, or non-compliance issues.
• Cross-Functional Collaboration: Work closely with cross-functional teams, including engineering, operations, quality, and regulatory affairs, to ensure alignment and consistency in mechanical documentation throughout the product lifecycle.
• Continuous Improvement: Identify opportunities for process optimization and efficiency improvements in documentation management processes, and implement best practices to enhance overall effectiveness.
• Training and Support: Provide training and support to internal stakeholders on mechanical documentation procedures, requirements, and tools to ensure compliance and facilitate effective use of documentation resources.

Qualifications:

• Bachelor’s degree in Mechanical Engineering or a related field. Master’s degree preferred.
  years of experience in mechanical engineering, with a focus on documentation management within the pharmaceutical industry.
• Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements.
• Proficiency in document management systems and software, such as Documentum, SharePoint, or similar platforms.
• Excellent attention to detail and organizational skills, with the ability to manage multiple projects and priorities simultaneously.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Knowledge of Six Sigma, Lean principles, or other continuous improvement methodologies is a plus.

For more information please contact nicolai.heyman@siblingrecruitment.com.