Senior Operations Specialist – III

Job Description

Job Summary:

• The Support Technician is an individual contributor with operational and technical responsibilities.
• Supporting Formulation, Laboratory and Experimentation Center (FLEx Center) activities (CQ&V, author/review SOPs, SAP, etc.),
• Leveraging experience in drug product manufacturing to support daily manufacturing and cleaning operations (development & GMP activities) within the FLEx Center, and
• Leveraging scientific/technical capabilities to support R&D development program activities as needed.
• The Support Technician position will flex between roles when necessary to drive program and development needs.

Duties and Responsibilities:

• Incorporate scientific and technical knowledge to complete assigned tasks.
• Collaborate with internal stakeholders to drive effective communication and completion of deliverables.
• Understand priorities from manager/supervisor to ensure task completion.
• Understand/act on guidance from supervisor where decisions are guided by policies, procedures, and business plan.
• Identify and help to resolve standard day to day quality, technical, and operational problems.
• Make decisions guided by policies and standard operating procedures.
• Compliance: Responsible for sustaining a culture of compliance (Safety, Environment, cGMP).
• Exercise judgement and decision making to ensure quality product is reliably produced.
• Utilization of Client Leadership Behaviors and Ways of Working to promote daily work activities.
• Keep informed on current policies/procedures and all other FLEx Center communications.
• Comply with all safety rules and regulations and take prompt corrective action concerning potential safety hazards.
• Support compiling safety related documentation requirements (e.g. process waste identification/collection)
• Help to identify root causes of manufacturing issues and implement corrective action.
• Author/review documentation related to operational procedures and/or reports.
• Oversee equipment support, cleaning activities, and the review/approval SOPs and technical documents.
• Technical support for manufacturing and packaging activities.
• Support equipment and cleaning processes.
• Equipment administration management.
• Adaptive to learn new skills or processes (SAP) to drive functionality of the FLEx Center to meet objectives.

Education:

• B.S. Degree in Science, Engineering or other technical field.

Experience:

• Minimum (4-5) years’ experience in a functional area, such as Operations, Technical Operations, Technology, Engineering.
• Minimum (4-5 years’ experience in relevant manufacturing or processing (bulk, solid oral dosage, solutions/suspensions, packaging, etc.) with working knowledge of current good manufacturing procedures (cGMP)

Software expertise:

• MS office, Inventory management system like SAP.

Personality:

• Detail Oriented.
• Team player.
• Independent.
• Flexible.