Technician, Operations - Oral Solid Dosage / Inhalation

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 oral solid dosage, sterile, and specialty dosage forms.  Positions will support development and clinical manufacturing and supply, as part of the FLEx-Sterile, FLEx-OSD, or RY119 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. 

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, capturing learnings 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 1st shift based in Rahway, NJ and 100% on-site.

Education Minimum Requirements: 

• High School Diploma/GED or higher

Required Experience and Skills:

• 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.

Preferred Experience and Skills:

• 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.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying