Technician, Filling Operations (Onsite)
$55,900–$88,100 year
On-siteRahway, New Jersey, United States
Job Summary
Prepare, operate, and clean equipment and facilities for clinical development and manufacturing processes. Maintain, inventory, and transport processing equipment, materials, supplies, and products while executing documentation functions to uphold Good Manufacturing Practice (GMP) operations. Troubleshoot equipment and systems to resolve issues, aiding technology and process development by capturing learnings. Participate in safety, quality, and continuous improvement initiatives, supporting investigations and corrective actions. Collaborate with formulators, engineers, and Quality teams to drive clinical pipeline success. This 1st shift, 100% onsite role in Rahway, NJ requires GMP experience and proficiency in automated sterile and oral solid dosage systems.
Required Qualifications
- 1+ years of relevant GMP Pharmaceutical experience, or equivalent (e.g. chemical, nuclear, military experience)
- Demonstrated written and verbal communication skills
- Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Equipment HMI use, SAP, Calibration/Maintenance Database Systems
- Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators
- Demonstrated ability to work and communicate both independently and as a part of a team
- Positions are 1st shift based in Rahway, NJ and 100% on-site
- High School Diploma/GED or higher
- Aseptic Filling
- Aseptic Manufacturing
- GMP Operations
- Manufacturing Operations
- Mechatronics
- SAP MES
- Sterile Manufacturing
Desired Qualifications
- At least 2 years GMP manufacturing/processing experience
- Familiarity with regulatory requirements and Good Documentation Practices (GDP)
- Experience with some of the following: highly complex and state of the art equipment, oral solid dosage, tablet compression, encapsulation, spray drying, film coating, dry powder inhalers, drug product device assembly lines, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, SAP or other ERP systems
- Associates Degree in science or related field
- BioWork Certificate (working in an FDA or similar regulated industry)
- Experience with automated systems (MES, SAP, or similar)
- Demonstrated troubleshooting / problem-solving skills
- Aseptic Processing
- Aseptic Technique
- Sterile Procedures
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