Viral Downstream III (1stShift)

Spectraforce Technologies; Swiftwater (Monroe County); On-site; USD 55,000 - 75,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Viral Downstream III (1st Shift) in Swiftwater, PA. The role supports downstream processing activities, including clarification, diafiltration, filtration, and centrifugation, with a focus on cGMP compliance and safety.

The assignment lasts 8 months and is onsite on 1st shift from 6:00 AM to 2:30 PM. Candidate requirements include strong documentation, mechanical aptitude, and ability to work in a regulated, collaborative environment.

Qualifications

• Thorough knowledge of cGMPs and regulatory requirements.
• Good documentation skills and legible handwriting.
• Ability to work independently and in a group.
• Strong mathematical and computation ability.
• Willingness to work weekends, holidays and overtime if necessary.

Responsibilities

• Performs production in accordance with volume fluctuation, business need, and effective cGMP procedures.
• Ensures materials required for production are available prior to use.
• Completes sampling and corresponding documentation.
• Participates in inventory management and related processes.
• Identifies production issues and relays them to management.
• Follows procedures to ensure safety and quality of the product.
• Participates in deviation investigations and root cause analysis as needed.
• Maintains timely quality documentation and records.

Skills

cGMP knowledge

Documentation

Mechanical aptitude

Computer skills

Troubleshooting

Teamwork

Attention to detail

Time management

Safety awareness

Education

Bachelor's degree preferred

Job description

Position Title: Viral Downstream III (1st Shift)

Work Location: Swiftwater, PA 18370

Assignment Duration: 8 Months

Work Schedule: 1st Shift 6 AM to 2:30 PM

Work Arrangement: Onsite

Position Summary

• 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.

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.
• All other duties as assigned.

Qualification & Experience

• 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