Associate, Technician Operations; Onsite

Position: Associate, Technician Operations (Onsite)
** Job Description
** 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.

This position will be responsible for hands-on processing activities that include room setup, equipment and material preparation, equipment assembly and disassembly, cleaning, and processing of raw materials into finished drug product. 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.
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* Key Responsibilities:

*** Prepares, operates, and cleans equipment and facilities used in clinical development and manufacturing processes.
* Maintains, inventories, and transports required processing equipment, materials, supplies, and products.
* Executes all documentation and clerical functions necessary to maintain good manufacturing practice (GMP) operations, using paper-based and electronic systems.
* Maintains detailed knowledge of process equipment and operations.  Troubleshoots equipment/systems to resolve issues and aid in technology and process development, and provides feedback to improve systems and processes.
* 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**:
* 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.
* Good eyesight for visual inspection.
* 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**:
* Experience with machine operations, electronics, or similar technology.
* Bio Work Certificate (for working in an FDA or similar regulated industry).
* Demonstrated troubleshooting / problem-solving skills.

First and second shift openings available#eligible for

ERP#PSCS#MSJR
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* Required Skills:

** Chemical Plant Operations, Cleanroom Gowning, CNC Operations, Computer Literacy, Conventional Machining, Drilling Machines, Equipment Set Up, Material Selection, Process Improvements, Production Scheduling, Quality Monitoring, Safety Procedures, Shift Work, TB Testing, Tooling Fabrication
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and Puerto Rico Residents Only:
** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems…