Manufacturing Technician Senior
1 month ago
About the Role:
We are seeking a highly skilled and experienced Sr. Manufacturing Technician to join our team at Takeda. As a key member of our production team, you will be responsible for executing all processes in production while strictly observing cGMP, environmental health and safety guidelines and any other related regulations.
Key Responsibilities:
- Assist supervisor in organizing, scheduling and directing other team members.
- Main interface with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, and validation.
- Involved in hands-on execution of manufacturing operations.
- Ensure and accurate generation of process documentation. Review documentation.
- Resolve issues related to equipment, process and compliance. Main troubleshooting/response person.
- Investigate any process problems and provide documentation.
- Participate on Continuous Improvement Teams and may serve in a leadership role.
- Train other team members and monitor training for newer team members.
- Help with process/equipment validation and data analysis
- Assign other project work and involvement in teams to team members.
- Represent the department in teams.
- May perform other duties as assigned.
Requirements:
- Requires a High school diploma or GED plus 4+ years of related work experience or associates' degree or higher and 2+ years related work experience.
- Knowledge of cGMP manufacturing and in-depth process knowledge of related manufacturing techniques/specialties.
- Knowledge of laboratory and pharmaceutical production equipment including: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
- Will apply quantitative analysis to analyze process performance.
- You must be proficient in different mathematical disciplines and be able to work with both the metric and USA standards of measurement.
- Good procedural writing skills.
- Knowledge of chemical and biological safety procedures.
- Knowledge of Microsoft Word and Excel.
Important Considerations:
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- Will carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
- Will stand for extended periods of time over an entire 8 or 12-hour shift.
- Will climb ladders and stairs while wearing special gowning.
- May require bending, twisting, reaching overhead, and squatting motions to perform certain tasks.
- Will work in controlled environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- May work in a confined area.
- Some Clean Room and cool/hot storage conditions.
- May require immunization before performing work within the manufacturing area.
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