Technical Lead Clean Room

at  MindCapture

JOB DESCRIPTION

The Technical Lead for Clean Room Operations will play a critical role in ensuring seamless daily production tasks within Manufacturing Operations. This role involves building strong partnerships across various departments, including Quality Control, Quality Assurance, Facilities & Engineering, Manufacturing Science & Technology (MS&T), Training, Planning, and the Warehouse. The Technical Lead will serve as the first point of contact for technicians and experts on the production floor, addressing production issues and working as part of a cross-functional team.

EDUCATION:

• Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or related field, or equivalent experience.

EXPERIENCE:

• Minimum 2 years in operations within a cGMP or ATMP environment in biotech/pharma.
• At least 2 years of aseptic/grade C GMP manufacturing experience.
• At least 1 year of team or project leadership experience.

CAPABILITIES, KNOWLEDGE, AND SKILLS:

• In-depth knowledge of cGMP regulations and EMEA guidance for cell-based products and cleanroom behaviors.
• Strong leadership and communication skills to effectively influence and guide team members.
• Ability to work independently, prioritize, and manage multiple tasks in a fast-paced environment.
• Strong organizational skills and ability to manage shifting priorities.
• Excellent analytical, problem-solving, and critical thinking skills.
• Proactive, hands-on approach with a can-do attitude.
• Tenacity to resolve issues and deliver results.
• Enthusiastic team player with a flexible mindset.
• Clear verbal and written communication skills with attention to detail.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Experience with MES/EBR is a plus.
• Ability to work shifts, including evenings and weekends, and accommodate unplanned overtime.

REQUIREMENTS:

• Shift work: Early, Late, and frequent weekends. More details will be provided during the initial contact.