Manufacturing Process Optimization Expert
1 week ago
We are seeking a highly skilled Manufacturing Process Optimization Expert to support our pharmaceutical industry projects in Denmark.
Key Responsibilities:- Develop and Optimize Production Processes: Collaborate with internal teams to design, implement, and optimize production processes for medical devices, pharmaceuticals, and biotech products.
- Ensure Regulatory Compliance: Maintain in-depth knowledge of GMP, ISO 13485, and Danish/EU regulatory requirements to ensure compliance throughout all project phases.
- Lead Validation Projects: Plan, execute, and document process validation, risk assessments (FMEA), and qualification activities to ensure seamless product transfer and scale-up into production.
- Troubleshoot Process Issues: Identify and resolve process-related problems to improve efficiency and quality, minimizing downtime and costs.
- Provide Expert Consulting: Offer guidance on process development and compliance to internal stakeholders, leveraging expertise to drive business success.
The ideal candidate will possess a strong background in process engineering within the medical, pharmaceutical, or biotech sector, with a proven track record of driving process improvements and ensuring regulatory compliance.
Requirements:- Proven Experience: At least [X] years of experience in process engineering within the specified sectors.
- Strong Knowledge: In-depth understanding of GMP, ISO 13485, and regulatory compliance requirements.
- Excellent Communication: Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.
- Fluent Language Skills: Proficiency in English and Danish languages.
This is a contract position, requiring flexibility and self-motivation to manage project deadlines independently.
Location:Available for on-site or remote project work in Denmark.
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