Upstream/Downstream Bioprocess Specialist

Mivado GlobalPerformance is seeking a Specialist in process/chemical engineering to join our Industrial design team to support the engineering, design, commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in various consumer goods/food/beverage/chemical markets. In this role, you will lead conceptual and detailed design efforts on key projects, train and mentor other junior engineers, and resolve design problems. We strongly encourage chemical engineers/process engineers with any type of bioprocessing/biomanufacturing/industrial large-scale fermentation experience to apply.

Responsibilities

• Works safely by EHS guidelines and adheres to Client cGMP Quality Management System requirements.
• Becomes subject matter expert (SME), remains trained and qualified in the area of expertise, and displays initiative in personal development opportunities further to enhance skills and expertise relevant to the position.
• Provide SME troubleshooting/oversight and support execution of the batch as needed to deliver the site key performance indicators of Right First Time and On Time Delivery.
• Builds partnerships and works collaboratively with the Operations Managers in mentoring Operations staffs with a focus on building talent depth and demonstrating positive behaviors as per company core values.
• Support operational production and facility maintenance planning as well as the transfer of new technologies/procedures/equipment to Operations to address production demands as per S&OP.
• Review manufacturing batch records, standard operating procedures, logbooks, or validation protocols required for Phase III projects as per ICH guidelines.
• Assists Operations group with deviation investigation and determination/implementation of preventative/corrective actions.
• Ensure audit readiness within Operations by identifying and addressing gaps as well as preparing storyboards and providing SME input during audit.
• Drive continuous improvement in Operations.

Skills and Experience:

• Must have at least 2+ yrs’ cGMP experience and technical expertise in Upstream and/or Downstream Processing.
• Have excellent written & verbal communication skills.
• Ability to work unsupervised, under pressure on multiple tasks and manage priorities independently.
• Possess strong organizational and planning skills and a commitment to excellence.
• Preferred to be educated to minimum Degree level in Biology, Chemistry or related field.
• Sufficient knowledge of Microsoft packages i.e. Word, Excel, PowerPoint, Microsoft Teams.
• Use of DeltaV, Dynamic 365, MasterControl, eDMS, Trackwise, SAP.

Additional Information

We are an equal opportunity employer.