The Manufacturing Technician will be responsible for the installation, setup, and qualification of manufacturing equipment within a regulated environment. The role focuses on equipment validation, specifically Installation Qualification (IQ), and requires a strong technical background, with experience in project leadership and process improvement. Experience in the medical device or pharmaceutical manufacturing industry is preferred.

Key Responsibilities:

• Equipment Installation and Qualification: Execute installation, setup, and qualification of manufacturing equipment according to regulatory and company standards. Focus on Installation Qualification (IQ) to ensure equipment is installed and functioning correctly.
• Regulated Environment Compliance: Work within a regulated environment, ensuring adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and other relevant regulations.
• Project Leadership and Process Improvement: Lead and support various projects related to equipment installation, process optimization, and continuous improvement initiatives.
• Documentation and Reporting: Prepare and maintain detailed documentation and reports of equipment installation, validation processes, and any deviations, ensuring accuracy and compliance.
• Technical Expertise: Utilize AutoCAD for equipment layout and design when needed. Apply knowledge of Manufacturing Execution Systems (MES) to support operations.
• Collaboration: Work closely with cross-functional teams, including Engineering, Quality Assurance, and Production, to ensure seamless execution of projects and equipment setups.

Key Skills and Qualifications:

• Experience: Minimum of 5 years as a Technician in a manufacturing environment, preferably within the medical device or pharmaceutical industry. Experience leading projects and driving process improvements is highly desirable.
• Technical Skills: Proficiency in AutoCAD is a plus. Strong knowledge of MES (Manufacturing Execution Systems) is required. Must be proficient in MS Suite, particularly Excel and Word.
• Lean Six Sigma: Knowledge of Lean Six Sigma principles is highly preferred for driving process improvements and optimizing workflows.
• Education: Bachelor’s degree (BS) in Engineering or equivalent preferred. Open to recent graduates with relevant industry experience. This is not an engineering position but requires a solid technical background and experience in the industry.

Additional Requirements:

• Work Environment: Must be comfortable working in a regulated environment with strict adherence to compliance and quality standards.
• Physical Requirements: Ability to work on a 5/8 or 4/10 shift schedule from 6:00 AM to 4:30 PM, with potential overtime as needed.