Seeking an experienced Manufacturing Manager to build and lead our production operations. The ideal candidate will have a strong background in manufacturing processes, cleanroom protocols, and technical documentation writing. This role will oversee production activities, ensure compliance with quality and regulatory standards, drive continuous improvement initiatives, and play a key role in scaling our organization. 

Duties and Responsibilities:• Oversee daily cleanroom manufacturing operations, ensuring compliance with GMP, ISO, and other relevant regulatory requirements. • Develop and implement manufacturing processes, work instructions, and SOPs to optimize efficiency and maintain quality standards. • Lead and mentor a team of production personnel, ensuring adherence to cleanroom protocols, safety regulations, and best practices. • Collaborate with R&D, Quality, and Regulatory teams to support new product introductions and process improvements. • Monitor production metrics, identify bottlenecks, and implement corrective actions to enhance efficiency and throughput. • Ensure proper documentation and record-keeping in accordance with regulatory and company standards. • Conduct root cause analysis and corrective action plans for process deviations and non-conformances. • Manage equipment calibration, maintenance, and validation activities within the cleanroom. • Support audits and inspections by internal teams and regulatory bodies. • Drive continuous improvement initiatives to enhance product quality, reduce waste, and optimize workflow. • Other responsibilities as required.

 

• Bachelor’s degree in Engineering, Manufacturing, Life Sciences, or a related field. • 5+ years of experience in manufacturing, with at least 3 years in a cleanroom environment. • Strong understanding of GMP, ISO 13485, FDA, or other relevant regulations. • Experience in writing and managing manufacturing documentation, SOPs, and work instructions. • Proven leadership experience in a manufacturing setting, with the ability to manage and motivate teams. • Excellent problem-solving, analytical, and organizational skills. • Strong attention to detail and commitment to maintaining high-quality standards. • Proficiency in manufacturing software, ERP systems, and process validation methodologies. Preferred Qualifications: • Experience in biopharmaceuticals, medical devices, or advanced materials manufacturing. • Lean Six Sigma certification or experience in process improvement methodologies. • Knowledge of automated manufacturing systems and statistical process control (SPC). 

 

Keenbee Talent Solutions is a Native Alaskan Women owned sdb specializing in the placement of highly skilled professionals in Accounting, Finance, IT/MIS and Cleared Federal Government positions.  Keenbee Talent has been in business since 1997 servicing New Mexico and the surrounding states with high results. Keenbee Talent Solutions is an equal opportunity employment agency.  We do not discriminate based on race, color, national origin, religion, ancestry, sex, age, disability, serious medical condition, spousal affiliation, sexual orientation, gender identity, or other classifications protected under the law.