Manufacturing Process Technician
Induce Biologics
Induce Biologics USA Inc. is proud to be the appointed representative for Red Rock Regeneration Inc. in the United States, overseeing the manufacturing, marketing, and distribution of their innovative regenerative medicine products. This collaboration places us at the forefront of delivering cutting-edge solutions to patients within the U.S. healthcare market.
By joining Induce Biologics USA Inc., you'll be part of a mission-driven team working with revolutionary technology that's reshaping the future of bone regeneration and making a real difference in patients' lives.
The Manufacturing Technician 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
- Maintain a controlled environment in the ISO cleanroom spaces, ensuring compliance with cleanliness standards
- 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.
- Execute 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.
- Accurately complete and maintain manufacturing records, logs, and reports adhering to Good Documentation Practices (GDP).
- Perform and document in-process or post-manufacturing Quality control testing as needed to ensure product specifications are met.
- Ensure adherence to Quality standards and collaborate with Quality Assurance to investigate non-conformities, deviations and implement corrective actions as needed.
- Collaborate with cross-functional teams, including Quality Assurance, R&D, and Customer Service on shared objectives.
- Work closely with Manufacturing management and team members to ensure efficient workflow and production schedules for the products.
- Assist in development and optimization of new manufacturing processes.
- Communicate effectively within Manufacturing and with cross-functional groups.
- May participate in outside audits and inspections as applicable.
- Adhere to all safety protocols and procedures to ensure a safe working environment.
- Ensures proper chemical handling and hygiene procedures are followed when performing manufacturing or QC duties.
- Perform routine cleaning and maintenance of cleanroom facilities and equipment as needed.
- Comply with regulatory requirements and internal policies related to manufacturing and quality.
- Assist in training other manufacturing technicians when necessary, including review of work performed.
Education/Experience Required
- High School Diploma (or GED) Required
- 2 - 4 years of 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)
Compensation Range
The salary for this position is expected to fall within the range of $25.00 to $30.00 / hr., depending on factors such as experience, training, and job-related skills. This range reflects what the employer reasonably expects to pay for the position. It is not a guarantee of compensation for the individual hire.