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Position Title: Viral Downstream III (3rd Shift)
Work Location: Swiftwater, PA 18370
Assignment Duration: 8 Months
Work Schedule: 3rd Shift 10 PM to 630 AM
Work Arrangement: Onsite
• Downstream 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 refractometers.
• 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 and 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.
• Strong self-driven work ethic with communication and time management skills.
• Commitment to personal and professional development by completing and giving training.
• Adaptability to work in a fast past/changing work environment.
• Attention to details, ability to follow instructions.
• Good documentation skills, legible handwriting.
• Basic mathematical skills and computation ability.
• Ability to work independently and in a group.
• Must have basic mechanical aptitude, computer skills, comprehension and retention skills.
• Troubleshooting and manual dexterity required.
• Thorough knowledge of cGMPs and regulatory requirements are required.
• Ability to lift up to 50lbs.
• Bachelor's Degree preferred.
• Previous production experience preferred.
• Hours for each position may vary.
• All positions require employees to stay until a job is completed.
• Every employee must be able to work weekends, holidays and overtime if necessary.
• Days off may not be consecutive and may vary from week to week (rotating schedule).
• Working hours are subject to change based on production demand.
• Employees may be required to take set days off in the middle of the week or work a rotating schedule.
• All antigen positions involve the production of active viruses.
• While risk of exposure is minimal, vaccinations are required for all areas, including Flu, Menactra, and Yellow Fever pending area assignment.
• Jewelry and makeup are not allowed on the floor.
• Perfume, hairspray, cologne, aftershave and/or any scents are not permitted.
• Artificial nails and nail polish are not allowed.
• The attire includes (but is not limited to) sterile scrubs, hairnets, beard covers, safety glasses, steel toe shoes, and in some areas Tyvek suits.
• Years of Experience: 6 - 9 Years