Biotech Process Development Engineer - Scale-Up & GMP

Kuros Biosciences, Inc.; Tipton; On-site; GBP 65,000 - 68,000; Full time

Job summary

A dynamic biotech company based in the UK is seeking a Technical Manufacturing Engineer to lead process development, ensure compliance with quality regulations, and support the launch of new manufacturing operations. The ideal candidate will have robust experience in manufacturing engineering and a proven track record in process validation. This full-time role requires strong leadership and problem-solving skills, alongside a solid educational background in engineering.

Qualifications

• 3+ years in Manufacturing, Process or Quality Engineering in an ISO13485-regulated industry.
• Experience performing IQ, OQ, PQ validations.
• Understanding of compliance with regulatory and safety standards (GMP, ISO, FDA).

Responsibilities

• Support the building of manufacturing facility in Alpharetta, Georgia.
• Validate and qualify manufacturing equipment and processes.
• Create and optimize manufacturing processes to improve efficiency and quality.
• Ensure compliance with medical device quality system requirements.
• Manage and allocate team resources across multiple projects.

Skills

Strong analytical and problem-solving skills

Excellent communication and interpersonal abilities

Proficiency in process control, lean methodologies and Six Sigma tools

Proficiency in data analysis tools (Minitab, PowerBI, Tableau)

Experience in developing Supplier Quality programs

Experience with regulatory environments (GMP, FDA, ISO)

Education

Bachelor’s degree in Engineering, Biology or a related field

Lean Six Sigma Green Belt or Black Belt Certification

Tools

Minitab

PowerBI

Tableau

Microsoft Dynamics 365

Job description

A dynamic biotech company based in the UK is seeking a Technical Manufacturing Engineer to lead process development, ensure compliance with quality regulations, and support the launch of new manufacturing operations. The ideal candidate will have robust experience in manufacturing engineering and a proven track record in process validation. This full-time role requires strong leadership and problem-solving skills, alongside a solid educational background in engineering.