Sr. Manufacturing Process Technician
1 month ago
Induce Biologics is a Bone Regeneration company. Our methods replicate the body’s native healing capabilities in order to create natural bone regeneration. The Induce Biologics NMPTM (Natural Matrix Proteins) unlocks the potential of naturally occurring growth factors, especially BMPs.
The Manufacturing Technician III will be responsible for the production of tissue products within a HTC/P manufacturing facility. This role will operate primarily in an ISO 7 Cleanroom environment, adhering to all applicable standard operating procedures (SOPs) and safety regulations.
Essential Functions & Responsibilities
- Execute and oversee manufacturing protocols, complex and basic, to produce tissue products following detailed SOPs.
- Prepare chemical buffers and solutions according to detailed SOPs, including QC testing as required.
- Operate and maintain manufacturing equipment and instruments according to applicable SOPs as needed.
- Maintain a controlled environment in the ISO cleanroom spaces, ensuring compliance with cleanliness standards
- Accurately complete and maintain manufacturing records, logs, and reports adhering to Good Documentation Practices (GDP).
- Work closely with Manufacturing management and team members to ensure efficient workflow and production schedules for the products
- Lead process improvement initiatives related to the manufacturing workflow.
- Collaborate with cross-functional teams including Quality Assurance, R&D, and Customer Service on shared objectives, including resolutions to complex manufacturing challenges.
- Perform and document in-process or post-manufacturing Quality control testing as needed to ensure product specifications are met.
- Adhere to strict gowning and decontamination procedures for all cleanroom activities
- Perform receipt and inspection of incoming raw materials and supplies used in manufacturing or QC as necessary.
- Perform routine cleaning and maintenance of cleanroom facilities and equipment as needed
- May participate in outside audits and inspections as applicable
- Assist Management in coordinating Manufacturing staff activities.
- Take lead in training other manufacturing technicians when necessary.
Education/Experience Required
- High School Diploma (or GED) Required
- Four (4) + years experience in a regulated (FDA, CAP/CLIA, ETC) manufacturing environment
- Experience in a Cleanroom environment (ISO 7 or lower), preferably within the biotech or medical device industry.
Education/Experience Preferred
- Bachelor's degree in a related field
- Handling of tissue in a manufacturing or QC setting
- Aseptic technique experience
- Leadership experience
Skill, Knowledge, and Abilities
- Excellent communication skills (verbal, oral, written)
- Strong attention to detail and ability to follow complex procedures accurately
- Working knowledge of Good Manufacturing/Tissue Practices (GMP/GTP)
- Problem-solving abilities
- Basic Microsoft Software functions (Excel, Word, Outlook)
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