Viral Downstream III (2nd shift)

Job Title: Viral Downstream III - 2nd shift

Job Location: Swiftwater, PA USA 18370

Job Duration: 12 Months

Shift: 2nd shift (2 PM to 10:30 PM)

Position Summary:

* JOB TITLE: RMF (Recombinant Manufacturing Facility) (previously BARDA)

* This position contributes as a member of a cross-functional team to support the startup of the cGMP manufacturing facility for Flublok /Panblok drug substance in Swiftwater PA and will later continue to support the cGMP commercial manufacturing of drug substances.

Key Responsibilities:

* Ensuring that processes are always compliant with FDA regulations.

* Works to become trained in all assigned training modules.

* Identifying and preventing deviations and assisting in investigation and root cause analysis.

* Helping with deviation investigations, Corrective and Preventive Actions (CAPA), Change Control Requests (CCR) and other assigned projects.

* Ensuring that quality documents like Electronic Batch Records (eBRs) and electronic logbooks are completed accurately and on time.

* Ensuring documentation is completed accurately and in real-time is crucial for compliance and quality control.

* Preparing areas for the next shift helping to maintain smooth operations and efficiency.

* Responsibly use material in an efficient matter to reduce waste.

* Sharing improvement ideas, issues, concerns to team members along with providing solutions.

* Proactive in identifying and solving production issues to ensure smooth operations.

* Follow all procedures put into effect to ensure your safety as well as the safety of others. Participate in monthly safety meetings.

* Report all safety issues, concerns, incidents, and near misses to the team leadership promptly.

* Actively participate in safety walkthroughs coordinated by the department's safety team.

* Provide input on potential safety issues and contribute ideas for the corrective and preventative actions.

Qualification & Experience:

* High School Diploma plus one-year experience in a cGMP environment or pharmaceutical experience.

* Associate Degree and Bachelor's degree with 0-year experience.

* Good mechanical skills, computer skills and is detail oriented.

* Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity.

* Proficiency in at least but not limited to one area of operation or product line.

* Previous cGMP / cGLP, Good Documentation experience.

* Previous experience in Aseptic Technique.