Bioprocess Hardware Specialist
Teva Pharmaceuticals
10 days ago
On-site
West Chester, PA
Operations
Responsibilities:
- Provide technical oversight and maintenance support for upstream (bioreactors), downstream (chromatography, filtration), and fill-finish clinical production skids.
- Perform advanced troubleshooting of hardware and software issues to maximize uptime and ensure stability of clinical manufacturing runs.
- Monitor and optimize equipment performance and engineering process flows to meet clinical production timelines.
- Oversee cleaning and maintenance of process skids (CIP/SIP) in alignment with validated clinical standards and safety requirements.
- Apply chemical safety knowledge to manage hazardous materials and ensure a safe, compliant operating environment.
- Collaborate with cross-functional teams on equipment upgrades and process optimizations for clinical scale-up.
- Lead documentation of technical equipment issues, root cause analysis, and CAPA within the clinical quality system.
- Provide technical guidance and training to operators on equipment handling, control interfaces, and safety procedures.
- Support validation and commissioning for new skids or modified manufacturing hardware.
Qualifications:
- Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, or related scientific field.
- Minimum 5 years’ experience in biologics pharmaceutical industry focused on clinical manufacturing environments.
- Demonstrated expertise troubleshooting and optimizing automated manufacturing systems (hardware and software/control logic).
- Thorough understanding of cGMP regulations, chemical safety standards, and pharmaceutical skid cleaning protocols.
Skills/Experience:
- Ability to manage the technical and operational complexities of manufacturing equipment.
Benefits:
- Comprehensive Health Insurance (Medical, Dental, Vision, Prescription) starting first day (if enrolled); 401(k) with employer match; Paid Time Off; Company-paid Life and Disability insurance.
Application Instructions:
- Internal applicants: apply through the internal career site on Twist.
- Provide technical oversight and maintenance support for upstream (bioreactors), downstream (chromatography, filtration), and fill-finish clinical production skids.
- Perform advanced troubleshooting of hardware and software issues to maximize uptime and ensure stability of clinical manufacturing runs.
- Monitor and optimize equipment performance and engineering process flows to meet clinical production timelines.
- Oversee cleaning and maintenance of process skids (CIP/SIP) in alignment with validated clinical standards and safety requirements.
- Apply chemical safety knowledge to manage hazardous materials and ensure a safe, compliant operating environment.
- Collaborate with cross-functional teams on equipment upgrades and process optimizations for clinical scale-up.
- Lead documentation of technical equipment issues, root cause analysis, and CAPA within the clinical quality system.
- Provide technical guidance and training to operators on equipment handling, control interfaces, and safety procedures.
- Support validation and commissioning for new skids or modified manufacturing hardware.
Qualifications:
- Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, or related scientific field.
- Minimum 5 years’ experience in biologics pharmaceutical industry focused on clinical manufacturing environments.
- Demonstrated expertise troubleshooting and optimizing automated manufacturing systems (hardware and software/control logic).
- Thorough understanding of cGMP regulations, chemical safety standards, and pharmaceutical skid cleaning protocols.
Skills/Experience:
- Ability to manage the technical and operational complexities of manufacturing equipment.
Benefits:
- Comprehensive Health Insurance (Medical, Dental, Vision, Prescription) starting first day (if enrolled); 401(k) with employer match; Paid Time Off; Company-paid Life and Disability insurance.
Application Instructions:
- Internal applicants: apply through the internal career site on Twist.