Manufacturing Technician

Job Title: Manufacturing Technician

Location: Swiftwater, PA

Duration: 12 months+ (Possibilities of Extension)

Shift: Multiple shift (first second, third)

Job Description:

Title: Manufacturing - Viral Downstream III

· Departments include Clarification : concentration/diafiltration processing and CIP tanks.

· General work includes filter testing, housing, sonication, set up tanks/filter assemblies.

· Purification sonication, build assemblies, preps receiving tanks, sanitize and load bowls for centrifugation, calibrate in-line refractometer Splitting - Assemble and Prep equipment, CIP/prep tanks, Centrifugation General area activities include sonication, building tanks, testing filters.

· Inactivation ? Clean/prep skid for processing, run diafiltration/concentration per established parameters Sterile Filtration - Set up tanks and filter trains for process, pull/dispense samples, pre/post use filter integrity testing Performs production in accordance with volume fluctuation, business need, and effective cGMP procedures.? Ensures all materials required for production are available prior to use. Completes sampling

Key responsibilities:

· Corresponding documentation as required.

· Completes move tickets and pick lists in an accurate and timely manner to ensure accurate inventory.

· Participates in all aspects of inventory management (SAP, cycle counting, ordering, etc.).

· Identifies all production issues and relays them to the management team. Works to prepare assigned areas for the oncoming shifts. Completes tasks and corresponding documentation as required by cGMP.

· Follow all procedures to ensure safety of self and others. Participates in monthly safety meetings. Report all safety issues, concerns, incidents and near misses to the team management. Follows effective procedures to ensure the production of a safe and efficacious product. Adhere to all SOPs and cGMP's Identifies areas of deficiency to the management team and offers potential suggestions for improvements. Participates in both deviation investigations when appropriate and implementation plans to ensure a quality product.? Works with the management team to complete deviation investigations and root cause analysis. Works to complete quality documentation (BPR's, logbooks, etc.) accurately in a timely manner. CFR (code of federal regulations) I PAl inspection readiness. FDA audit understanding and awareness.? Participates in cross functional teams where necessary to complete projects in an effective and timely manner. All other duties as assigned.

Full-Time