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Quality Assurance Inspectors work “hands-on” on the production floor, inspecting packaging, labeling and finished products to ensure products comply with Company policies and standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) requirements. Quality Assurance Inspectors are responsible for sampling, inspection and physical testing of packaging components. Quality assurance Inspectors ensure procedures and documentation meet cGMP and Quality standards. As a key support member of a rapidly growing company, the QA Inspector must be flexible in their approach to work and be comfortable with taking on new challenges.
The ability to read, write and speak English is a...
The Process Mechanic Apprentice will learn to perform the job of a Process Mechanic to perform mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and process machinery through the completion of a comprehensive virtual classroom and on-the-job learning program. The Process Mechanic Apprentice will do so while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies.
The Process Mechanic, Off Shift will perform activities including, but not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and process machinery while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. This position may also include light facilities maintenance. This is a Pitman Schedule position.
The Process Mechanic, Off Shift will perform activities including, but not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and process machinery while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. This position may also include light facilities maintenance. This is a Pitman Schedule position.
The Process Mechanic Apprentice will learn to perform the job of a Process Mechanic to perform mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and process machinery through the completion of a comprehensive virtual classroom and on-the-job learning program. The Process Mechanic Apprentice will do so while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies.
The Materials Coordinator II will assist in the efficient receipt, storage, movement and inventory of items throughout the Warehouse.
Hours are Monday - Friday 7:00 am - 3:30 pm
The Automated Operator is a high-level machine operator capable of operating automated equipment. This role carries additional responsibilities than of its junior role, Operator 1, but will not require personnel to operate within sterile areas as do the Gown Qualified Operators. The Automated Operator is directly responsible for their assigned machine, including preparing for production, production efficiency, and closeout of production. This role is also responsible for documentation, escalation of issues, and coaching and directing personnel supporting their assigned machine.
This position is responsible for Equipment, critical utilities and facilities Validation activities (i.e. included but not limited to Manufacturing and packaging equipment, critical utilities including WFI, compressed gases, clean steam, etc.), that supports commercial and new R&D drug product development activities in support of the specific client projects involving all delivery systems manufactured at Renaissance Lakewood LLC, NJ plant.
This highly technical and highly specialized position is responsible for generating, reviewing, and approving qualification protocols, deviations and reports; as well as scheduling manpower activities, providing internal and external customer feedback, ensuring...
Renaissance is currently recruiting for a Spring Semester 2025 Co-Op for our Process Engineering Team.
The Facilities Maintence Mechanic will demonstrate a high level of Facility Maintenance ability and critical thinking skills, and aptitude for solving complex problems while demanding integrity, sense of urgency, accountability and attention to detail.
The Automated Operator is a high-level machine operator capable of operating automated equipment. This role carries additional responsibilities than of its junior role, Operator 1, but will not require personnel to operate within sterile areas as do the Gown Qualified Operators. The Automated Operator is directly responsible for their assigned machine, including preparing for production, production efficiency, and closeout of production. This role is also responsible for documentation, escalation of issues, and coaching and directing personnel supporting their assigned machine.
The Validation Engineer II is responsible for duties associated with qualifying manufacturing and packaging equipment and Pharmaceutical utilities, including: HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen consistent with cGMP requirements for clinical manufacturing, scale-up and commercial manufacture of sterile and specialty pharmaceutical products.
Major job functions include: generation of qualification / validation documents, execution of qualification / validation...
Primary Responsibility for execution of bulk product batch processing, inclusive of all process related and administrative activities, as well as Equipment Preparation activities as declared in Compounder 1.
Operate filling equipment in a controlled or non-controlled area to fill and seal product into containers as specified by batch record, and in accordance with all operational SOPs and cGMP requirements.
The Gown Qualified Operator is responsible for the full spectrum of duties in assigned filing room. This may include but is not limited to: set-up of room and equipment for production, operate equipment to meet product specifications and batch record requirements, ensures correct components and product according to production schedule and batch record, equipment and room cleaning and sanitization, etc
The Automated Operator is a high-level machine operator capable of operating automated equipment. This role carries additional responsibilities than of its junior role, Operator 1, but will not require personnel to operate within sterile areas as do the Gown Qualified Operators. The Automated Operator is directly responsible for their assigned machine, including preparing for production, production efficiency, and closeout of production. This role is also responsible for documentation, escalation of issues, and coaching and directing personnel supporting their assigned machine.
The Automated Operator is a high-level machine operator capable of operating automated equipment. This role carries additional responsibilities than of its junior role, Operator 1, but will not require personnel to operate within sterile areas as do the Gown Qualified Operators. The Automated Operator is directly responsible for their assigned machine, including preparing for production, production efficiency, and closeout of production. This role is also responsible for documentation, escalation of issues, and coaching and directing personnel supporting their assigned machine.
The Automated Operator is a high-level machine operator capable of operating automated equipment. This role carries additional responsibilities than of its junior role, Operator 1, but will not require personnel to operate within sterile areas as do the Gown Qualified Operators. The Automated Operator is directly responsible for their assigned machine, including preparing for production, production efficiency, and closeout of production. This role is also responsible for documentation, escalation of issues, and coaching and directing personnel supporting their assigned machine.
Perform activities including, but not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and process machinery while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. This position may also include light facilities maintenance.
Perform activities including, but not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and process machinery while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. This position may also include light facilities maintenance.
The Sr. Production Planner is responsible for developing and optimizing production plans that align with company goals, client demand, capacity constraints and ensures efficient utilization of resources and maintaining supply chain integrity.
This role focuses on planning for a team that serves as a communication hub of inputs to our site plan in a fast-paced CDMO environment. The ideal candidate works and collaborates with internal teams to support commercial production, preventive maintenance, engineering projects and product development scheduling throughout the organization.
They must be comfortable independently coordinating and driving alignment cross-functionally throughout the organization. The candidate must be highly...