Cleanroom Supervisor
Stage 2 Contract Engineering is seeking a skilled and experienced individual to join or team as a Cleanroom Supervisor. In this role, this individual will actively monitor and oversee production activities, ensuring adherences to SOPs, cGMPs and quality standards.
About us: Stage 2 is an engineering and prototype firm in Farmington Hills, Michigan that creates useful solutions to the worlds most pressing problems. Stage 2 works to find, develop, and manufacture products that enable the unlucky half of the world to meet basic needs for electricity, clean water, and effective healthcare. Those products include the HANS PowerPack, HANS Solar Briefcase, and HANS Free Electric bicycle; the HANS Premium Water Appliance; and the Renew ECP apparatus. Stage 2 has other clean energy, clean water, and medical technologies that are still under development.
ROLE RESPONSIBILITIES
- Supervise and provide guidance to a team of Cleanroom operators.
- Set clear expectations, provide training, and foster a positive work environment to promote teamwork.
- Ensuring timely execution and optimization of resources.
- Monitor manufacturing processes to maintain efficiency and meet production targets.
- Collaborate with Plant Management and Quality Assurance to ensure smooth operations and timely product delivery.
- Enforce compliance with cGMP (current Good Manufacturing Practices) guidelines and company quality standards.
- Perform batch record reviews and ensure adherence to SOPs (Standard Operating Procedures) and regulatory requirements.
- Investigate and address any quality deviations or non-conformities, implementing corrective and preventive actions as necessary.
- Ensure compliance with environmental, health, and safety regulations to maintain a safe working environment.
QUALIFICATIONS
- Bachelor’s degree in a relevant field (e.g Scientific/Engineering) or equivalent experience.
- A minimum of five (5) years of Cleanroom supervision responsibility required.
- Proven experience as a Supervisor or Team Leader in a Cleanroom manufacturing environment.
- Experience with aseptic manufacturing, isolator technology and lyophilization processes
- Strong knowledge of cGMP regulations, quality standards, and pharmaceutical manufacturing processes.
- Excellent leadership and communication skills with the ability to motivate and engage a diverse team.
- Sound problem-solving and decision-making abilities to address production issues and implement effective solutions.
- Attention to detail, organizational skills, and the ability to prioritize and manage multiple tasks simultaneously.
- Proficiency in using manufacturing software systems, MS Office applications, and data analysis tools.
Equal opportunity employer