Manufacturing Associate 5, Drug Product (2nd Shift 3PM-1130PM)
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Job Location:
Holly Springs, MS - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Department:
Job Summary
Position Overview
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.
Job Description
What Youll 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 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.
ADA Information
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 ().
Required Experience:
IC
Key Skills
- Marketing
- Quality Assurance
- Agile
- Product Demos
- Analysis Skills
- Jira
- Project Management
- Product Management
- Qualitative Analysis
- Confluence
- Internet Of Things
- Product Development
