(Contractor) Equipment Specialist

The Equipment Specialist is a key technical role within Curium Pharma's operations team to ensure implement process improvements and maintain the current state of the equipment. The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge in aseptic filling, sterile processing, and/or labeling.

This position will partner and lead internal operations continuous improvement initiatives. The ideal candidate must understand and be able to adapt to the changing needs of a manufacturing environment while providing support to the process engineers and operations team in troubleshooting, repair and preventative maintenance of manufacturing equipment and processes. You will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. You will also be expected to demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and inspire problem solving and solution driven thinking.

Work Schedule: Monday - Friday 8am-4:30pm

* Resolve issues that arise in day to day running of operation and providing timely responses and solutions

* Function closely with operations personnel to understand their interaction with equipment and resolve issues they face

* Implement solutions in collaboration with cross-functional technical teams and site leadership team

* Support filling equipment, formulation process, visual inspection equipment, and/or labeling process.

* Evaluate and improve efficiency of manufacturing instruments, equipment, and tools

* Evaluate and implement new changes

* Support operations through standard operating procedure revision

* Participate and/or support process FMEAs to understand process and product risks

* Provide technical support to manufacturing activities

* Work flexible hours to ensure production facility coverage

* Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

* Bachelor's degree in engineering field or Bachelor's degree in life sciences with 3+ years of relevant work experience

* Or High School Diploma/GED 8+ years of relevant work experience

* Lean Six Sigma Certification

* Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices

* Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), visual inspection, and labeling

Working Conditions:

* Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.

* Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.

* Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.

* Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.

* May be required to sit or stand for long periods of 8+ hours a day while performing duties.

* Must possess good hand-eye coordination; close attention to detail is required.

* Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.

* Willingness to complete safety training within allotted timeframes, and work in a team-based environment.

* Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.