Sterile Processing Technician

Clean Room Technician

Stage 2 Contract Engineering is seeking a skilled and detail-oriented Clean Room Technician to join our team. This Clean Room Technician position involves a working knowledge of Clean Room practices, execution compliant with good manufacturing practices, and effective time management. He/She will be responsible for the safe, efficient, and routine manufacturing of products.

About us: Stage 2 is an engineering and prototype firm in Farmington Hills, Michigan that creates useful solutions to the world's 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

• Operate manufacturing equipment, including but not limited to vial washers, depyrogenation ovens, filling machines, autoclaves, and packaging equipment.
• Ability to operate in a clean room environment.
• Perform cleaning and sanitization of equipment.
• Follow batch records, SOPs, and work instructions to accurately execute production processes and ensure compliance with cGMP guidelines and regulatory requirements.
• Record GMP data on controlled documentation accurately and precisely.
• Conduct in-process checks, inspections, and sampling to verify product quality and compliance with specifications.
• Document all production activities, observations, and test results accurately and maintain batch records and production logs.
• Comply with regulatory requirements, quality standards, and company policies related to clean room manufacturing and workplace safety.
• Participate in validation activities as needed during initial qualification and requalification.

Qualifications

• High school diploma or equivalent; additional technical or vocational training in pharmaceutical manufacturing or related field is a plus.
• Knowledge of cGMP guidelines, quality control principles, and manufacturing processes in the pharmaceutical sector.
• Familiarity with pharmaceutical manufacturing equipment and processes.
• Familiarity with aseptic processing/handling, a plus.
• Attention to detail, ability to follow SOPs and instructions precisely, and maintain accurate documentation.
• Strong organizational skills and ability to multitask in a fast-paced manufacturing environment.
• Basic computer skills for data entry, equipment monitoring, and documentation purposes.
• Good communication skills and the ability to work effectively as part of a team.

Equal opportunity employer