Downstream Processing Technician II

Skills at this level

Purification unit operations

— Sets up, operates and cleans chromatography systems, tangential-flow/UF-DF skids and viral filtration equipment to produce and polish bulk biologic drug substance.

Buffer and media preparation

— Weighs, mixes and QC-checks buffer and media solutions to specified recipes and stages them for downstream production runs.

Good Documentation Practice (GDP)

— Records batch parameters and completes/reviews batch records contemporaneously and accurately so downstream work meets Right-First-Time and data-integrity requirements.

Batch record execution

— Follows Master Batch Records and study protocols step-by-step to run downstream operations in a CGMP-compliant sequence with correct hold points and in-process checks.

Cleanroom and 5S discipline

— Maintains cleanroom facilities and downstream equipment in a controlled, organized state using 5S practices to preserve product and environmental integrity.

Downstream equipment maintenance and troubleshooting

— Performs preventive maintenance and diagnoses in-process faults on chromatography, filtration and mixing equipment (column packing, TFF flux, filter integrity) to keep runs on track.

Raw material inventory control

— Monitors, orders, receives and distributes downstream raw materials and consumables so scheduled runs are supplied without stockouts or expiry issues.

Deviation and CAPA authoring

— Investigates downstream floor deviations, documents root cause and writes corrective and preventive actions to prevent recurrence.

SOP and MBR authoring

— Writes and revises Standard Operating Procedures and Master Batch Records for downstream unit operations, translating process intent into executable GMP instructions.

Equipment commissioning and qualification

— Specifies, commissions and executes qualification/requalification protocols for new and existing downstream purification equipment.

Process transfer

— Transfers downstream processes between process development, the manufacturing floor, CMOs and partner sites, converting development conditions into qualified production procedures.

Working lead coordination

— Plans run readiness, sequences equipment turnover and assigns tasks across a downstream suite or shift, guiding and training less experienced associates without formal supervisory authority.