Senior Bioprocess Associate Job Summary
The ideal candidate will play a key role in supporting and delivering process and equipment operation activities during manufacturing operations.
Key Responsibilities:
* Coordinate scheduling activities to ensure all production supplies are available for day-to-day operations.
* Organize daily activities and work with BPAs to execute tasks in a safe, compliant, and efficient manner to maintain production schedules.
* Act as designee for the Shift Lead in their absence, including attending and chairing meetings, holiday cover, using escalation processes, and acting as a point of contact for BPAs.
* Perform all core production tasks in upstream and/or downstream areas, along with ancillary tasks.
* Write, review, and update Standard Operating Procedures (SOPs), On the Job Training (OJTs), Production Batch Records (PBRs), Logbooks, Training Competencies, and Work Instructions.
* Carry out all production operations in assigned areas as directed by relevant SOPs and Manufacturing Batch Records.
* Perform initial troubleshooting of issues identified during routine operations.
* Adhere to Right First Time (RFT) principles and assist in training colleagues on SOPs, process execution, and equipment operation.
* Support the development of training matrices and ensure compliance to training requirements.
* Escalate any deviation from SOPs and batch records and provide assistance with investigation through the Trackwise system.
* Lead and participate in shift handovers, liaise with Shift Leads regarding issues, and highlight process bottlenecks.
* Assist in facility, equipment start-up, and validation activities, providing input on equipment installation, operation, and troubleshooting.
* Work with cross-functional teams to develop and validate the Biologics manufacturing facility.
* Develop and demonstrate individual skills as subject matter experts and display technical leadership by driving improvements and excellence within specific aspects of the manufacturing operation.
* Assist in maintaining a safety-oriented culture, cGMP/GDP compliant work environment, and drive Continuous Improvement (CI) and Zero Defects.
* Support Equipment Design, HAZOP, and risk assessments as required.
* Consistently deliver on specific area Key Performance Indicators (KPIs), such as Safety, Quality, Schedule delivery, EHS metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance, and team training.
* Provide assistance and support maintenance, engineering, quality, or other colleagues as requested.
Requirements:
* Degree in science or chemical engineering preferred; or equivalent demonstrated experience in the biopharmaceutical industry.
* Demonstrated experience as an SME in a biopharmaceutical operation.
* Previous experience acting as designee to the shift lead role is preferred.
* Experience in coordinating shift activities and escalating issues to ensure all manufacturing processes are adhered to.
* Self-motivated with excellent communication and interpersonal skills.
* High level of adaptability working in a fast-paced environment and champion change.
* Ability to positively influence and work well with others.
* Leadership and support to junior team members.
* Strong analytical skills and ability to troubleshoot.
* Comfortable making risk-based decisions.
Benefits:
* Bonus
* Pension
* VHI