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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 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...
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 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
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...
3 to 5 years’ experience with designing processes and equipment for pharmaceutical manufacturing. Experience in aseptic filling is a plus. Serve as the technical subject matter expert for filling or packaging equipment. Responsible for the overall maintenance and reliability of automated manufacturing lines and help troubleshoot equipment issues in a fast-paced environment. Responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production process by applying systems engineering principles and technology of chemistry, physics, and equipment engineering.
The Compounder I is an entry level position to Compounding Department with emphasis on ensuring that equipment used to process aseptic and non-aseptic products has been cleaned, sanitized or sterilized, as required by specific documentation or procedures. This entails performing automated and manual equipment cleaning prior to sterilization, placing cleaned equipment into autoclaves, starting and monitoring autoclaves, unloading equipment from autoclaves, and delivering equipment to areas of use.
Perform Clean-In-place (CIP) and Steam-In-Place...
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.
The Continuous Improvement Operational Excellence Engineer II will be responsible to utilize lean tools to drive for business excellence and cost reductions initiatives through process simplification and the overall business transformation.
The Manager, Assembly and Packaging is responsible for leading the Assembly and Packaging focused team. The team includes Assembly and Packaging Supervisors, Coordinators and Direct Labor.
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.
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 Pittman Schedule position.
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.
