Senior Bioprocess Associate MFG 7

WuXi Biologics•Dundalk, MD

8d•Onsite

About The Position

As Senior Bioprocess Associate MFG 7, you will be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will be reporting to the Bioprocess Shift Lead. You will be responsible for supporting and delivering on process and equipment operation activities during manufacturing operations. You will be expected to be a subject matter expert in Upstream and/or Downstream purification and in process analytical equipment’s. A key responsibility of this role will be to coach and mentor Bio-Processing Associates (BPA). Detailed knowledge of the process will be vital to ensure optimum process operations, as well as a high level of understanding of GDP.

Requirements

Demonstrated experience of working in a cGMP/GDP environment
Strong demonstrated knowledge in upstream or downstream processing is essential.
Requires understanding of scientific principles, operational aspects of production equipment and automation control.
Demonstrate experience as an SME in a biopharmaceutical operation.
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.
Show leadership and support to junior team members.
Ability to troubleshoot and strong analytical skills.
Comfortable making risk-based decisions.
Results driven and a proven record of being a high achiever.

Nice To Haves

Experience in lean 6 Sigma tools in standard work and 5S are an advantage.
Good level of knowledge and execution of validation protocols is an advantage.
Experience of operating automated control systems such as Delta V, Unicorn or similar systems is desired.
Demonstrated career progression is desirable.
Previous experience acting as designee to the shift lead role is preferred.
Experience in coordinating shift activities and escalation of issues to ensure all manufacturing processes are adhered to.

Responsibilities

Provide co-ordination of scheduling activities and ensures all production supplies are available for day-to-day operations.
Organise daily activities and work with BPA’s in executing those activities in a safe, compliant, and efficient manner to maintain production schedules.
Act as designee for the Shift Lead in their absence. Duties in this situation would include but is not limited to attending and chairing meetings, Bio-Processing Shift Lead holiday cover, use escalation process, act as a point of contact for BPA’s during shift.
Perform all core production tasks in the areas of upstream and/or downstream and all ancillary tasks.
Write, review and update of area Standard Operating Procedures (SOPs), On the Job Training (OJT’s), Production Batch Records (PBRs), Logbooks, Training Competencies and Work Instructions.
Carry out all production operations in the assigned area as directed by the relevant SOPs and Manufacturing Batch Records.
Perform initial troubleshooting of issues identified during routine operations.
Always adhere to Right First Time (RFT) principals.
Assist where necessary with the training of colleagues in SOPs, process execution and equipment operation.
Support the development of training matrices and ensuring compliance to training requirements.
Escalation of any deviation from SOPs and batch records and provide assistance with investigation of deviations through the Trackwise system while using scientific, engineering, and lean principles.
Lead and actively participate in shift handovers.
Liaise with Shift Lead regarding issues which may arise from the production area including highlighting process bottlenecks.
Assist in any facility, equipment start-up and validation activities.
Provide input on equipment installation, operation and troubleshooting to support introduction of new products into sustaining operations.
Work with cross functional teams to facilitate the development and validation of the Biologics manufacturing facility.
Develop and demonstrate individual skills as subject matter experts and are required to display technical leadership by acting as ‘Champion’ to drive improvements and excellence within specific aspects of the manufacturing operation within the shift team.
Assist in driving and maintaining a safety orientated Culture, cGMP/GDP compliant work environment always.
Liaise with other groups and individuals to ensure planning of tasks are effective and linked into the manufacturing process plan.
Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Method 1, 2 etc.) to optimize efficiency and drive the culture of Continuous Improvement (CI) and Zero Defects.
Support Equipment Design, HAZOP, and risk assessments as per requirements.
Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., Safety, Quality, Schedule delivery, EHS metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training.
Provide assistance and/or support maintenance, engineering, quality, or other colleagues as requested.
Conducts all activities that are in accordance with Company policies & SOPs, WuXi values, & global regulatory guidelines (including cGMP/cGLP/cGLP), environmental guidelines, as appropriate, etc.
Advise management of non-conformance issues and opportunities for (CI).
Identify and manage equipment training gaps and requirements.
Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
Will be flexible to take on additional tasks and responsibilities at the discretion of the Bio-Processing Shift lead.
Will act as a role model for the Manufacturing function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture.