Viral Downstream III (2nd shift)

Position Title: Viral Downstream III (2ndt Shift)

Work Location: Swiftwater, PA 18370

Assignment Duration: 8 Months

Work Schedule: 2nd Shift 2:00PM to 10:30 PM

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