Job Description
Position Title: Viral Downstream III
Work Location: Swiftwater, PA 18370
Assignment Duration: 12 Months
Work Schedule: 2nd shift
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.
Key responsibilities:
- 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.
Requirements:
- 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