Our Danish client is seeking an Assembly Expert to join a team of Subject Matter Experts (SMEs) supporting the transfer of commercial-stage products to vendors/CMOs across Europe, China, and the US. This position is part of a new SME team based in Denmark, focusing on product transfer, troubleshooting, and ensuring the technical success of these activities.
Key Responsibilities:
- Act as the technical SME for assembly processes during the transfer of products to external vendors/CMOs.
- Set up and design new assembly lines, ensuring efficiency, compliance, and alignment with high-complexity product requirements (e.g., assemblies involving 5-10+ components).
- Review and optimize existing assembly lines, identifying and resolving product assembly line issues to support smooth production processes.
- Support CMOs in meeting GMP standards and ensure a seamless transfer process, addressing challenges and troubleshooting in real time.
- Take ownership of technical content, such as specification packages, drawings, procedures, protocols, and processes, and act as the first point of communication for CMO sites.
- Provide technical guidance to CMOs, ensuring their readiness for product transfers and addressing complex technical questions.
- Leverage internal SME networks for escalation and support when necessary.
- Work collaboratively with CMOs, internal teams, and stakeholders to ensure successful outcomes.
Requirements:
- Experience: 10+ years of hands-on experience in assembly processes at a mid-senior level. Demonstrable experience in executing similar transfer activities within the last 2-4 years, ensuring familiarity with the latest technologies and regulatory environments.
- Technical Skills:
- Proven expertise in setting up and designing new assembly lines.
- Ability to troubleshoot and resolve advanced assembly line challenges.
- Experience with highly complex assemblies (5-10+ components) is required.
- Industry Knowledge: Strong background in medtech and ISO 13485 compliance is essential. Experience with drug delivery systems and autoinjectors is a significant advantage.
- Communication: Excellent English language skills, both written and verbal.
- Vendor Knowledge: Prior experience with the client's vendors is a strong plus (specific vendors to be disclosed upon confirmation).
- Regulatory Understanding: Strong knowledge of GMP standards and a proactive approach to ensuring compliance at CMO sites.
Additional Information:
- The position will involve working closely with international CMOs, some of which may not currently meet GMP standards.
- This is a contractor role requiring on-site work in Denmark, with collaboration across global stakeholders.
- Candidates must demonstrate a proactive and problem-solving mindset to handle the complexities of the transfer process.
Location: Denmark
Contract Type: Contractor
Start Date: Immediate availability preferred
If you're an assembly expert with the technical expertise and experience to lead high-complexity product transfers in a regulated environment, we encourage you to apply!
