Technician, Filling Operations; Onsite

Position: Technician, Filling Operations (Onsite)
** Job Description
**** POCS – Rahway:
Technician, Operations (FLEx Sterile Filling Technician)
** Level: O2

Job Family:
Manuf/Operations
** Technician, Operations
** Pharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.  Positions will support development and clinical manufacturing and supply, as part of the FLEx-Sterile team, specifically in Filling.

This position will be responsible for hands-on processing activities that include sterile filling, lyophilization, and capping.  These individuals are expected to partner with, and support formulation development colleagues in further understanding and knowledge capture of processes, which could include providing feedback on product and process development.

These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects.  Positions may also support commissioning, qualification, and demonstration of new equipment and technologies.  Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline.
*
* Key Responsibilities:

*** Aseptic Processing:
Perform sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).  Able to perform aseptic interventions within a Grade A Isolator.
* Aseptic experience:
Experience in working in Grade A environment is required, including aseptic qualification and performing environmental monitoring.
* Isolator Operation:
Operate and maintain large complex isolators, ensuring optimal performance and adherence to safety protocols.
* Documentation:
Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system.  Knowledge of PAS-X is preferable.
* GMP:
Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.  Able to report any recurring issues or trends to management for further investigation.
* Cleanroom Environment:
Able to gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors

* Collaboration:

Able to communicate clearly with team and work closely with other teams to ensure on time delivery.
* Training and Compliance:
Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.
* Leadership:
Able to identify and escalate issues, perform basic troubleshooting, and capturing learnings to improve systems and processes.  Also attends and actively participates in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
* Supports investigations and implementation of corrective/preventative actions.

Positions are based in Rahway, NJ and 100% on-site.
** Education

Minimum Requirements **:
* High School Diploma/GED or higher
** Required Experience and Skills**:
* 1-3 years of relevant GMP Pharmaceutical experience, or equivalent (e.g. chemical, nuclear, military experience).
* Good eyesight to perform detailed inspections
* 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.
* Flexibility working overtime is a requirement in manufacturing
** Preferred Experience and Skills**:
* At least 2 years GMP manufacturing/processing experience.  Familiarity with regulatory requirements and Good Documentation…