This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This position will ensure drug product manufacturing start up phase is supported from a knowledge standpoint and will then help the supervisor lead the manufacturing effort after start up phase.

What You’ll Do

During Project Phase:

• Key contributor in supporting the preparation for operational readiness related to drug product manufacturing.
• Supports projects related to:
Commissioning and qualification of equipment, procedure review and/or creation, support onboarding of manufacturing staff, development or Transfer of Manufacturing business processes, new item creation, or single-use assembly transfer or design.
• 0-25% travel (international and/or domestic) may be required.

In Operations:

• Adheres to strict safety protocols and contribute to culture of safety within the manufacturing environment. Leads, executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control within a functional area, ensuring
compliance with Standard operating procedures (SOPs) and cGMP regulations.
• Oversees and/or performs in-process testing (pH, conductivity, visual inspection)
• Executes validation protocols according to cGMP Standard Operating Procedures (SOPs). Provides approval as a backup to the supervisor.
• Maintains training to perform all required activities.
• Trains and mentors manufacturing associates to enhance team capabilities.
• Supports scheduling daily activities on the manufacturing floor and act as a back-up for the supervisor, as needed.
• Leads troubleshooting as required for operational issues.
• Assists the supervisor with shift huddles and tier escalations, investigation, and continuous improvement (CI) projects, as needed.
• Area lead for cycle counts and materials management
• Other duties as assigned.
• After start-up phase this role requires shift work (weekend and potential for nights)

Basic Requirements

•  High school diploma or GED with 8 years’ experience in life sciences manufacturing OR
• Associate degree with 6 years’ experience in life sciences manufacturing OR
• BA/BS, preferably in Life sciences or Engineering 4 years of experience in life sciences manufacturing OR
• Equivalent Military experience

Preferred Requirements

• Proficient understanding of cGMP regulations and pharmaceutical industry standards.
• Fully Qualified in a functional area (ex. Drug Product Formulation and
  Filling, Weigh and Dispense or Cell Culture or Purification).
• Bioworks Certification

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Will work in environment which may necessitate respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
• Ability to discern audible cues.
• Ability to ascend or descend ladders, scaffolding, ramps, etc
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
• Ability to conduct work that includes moving objects up to 33 pounds
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in heights greater than 4 feet.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).