Posted on 15th May 2019
Manufacturing Engineer Technician II – Focus Factory Cold Products
Summary of Position:
Performs all tasks associated with inspecting, labeling and packaging manufactured products according to cGMP Guidelines in order to meet production demands. Performs all tasks associated with Pre-Labeling for all Radioactive Products as well as providing back up support for the Cold Products Area 9 and Aseptic Suite Group. This position will report to the Cold Products Packaging Supervisor.
Position and Schedule:
Maryland Heights CP
Weekend and off shift overtime as needed
- Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP’s and FDA regulations.
- Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the area.
- This position will coordinate with Staging, Warehouse, Label Control, and Production Supervisors to plan, schedule, and execute all aspects of the area.
- Monitor and inspect product quality to ensure compliance with standards and specifications.
- Must pass Visual Acuity and Color Vision Test and must be able to lift 50lbs.
- Adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance.
- Follow all written procedures and verbal instructions.
- Perform Batch Record calculations and maintain all documentation according to cGMP Guidelines.
- Follow detailed instructions and communicating effectively, both written and verbally.
- Set up, operate, monitor and clean production equipment and processes in accordance with current good manufacturing practices and standard operating procedures.
- Order and maintain inventory of materials and supplies.
- Act as demonstrators and/or qualifiers for processes and procedures during the training of new employees.
- Assist in developing and revising SOPs as needed.
- Troubleshoot problems with equipment, devices, or products.
- High school diploma or equivalent required. College level course work in Mechanics, Engineering Technical trade, or Chemistry preferred.
- 3 to 5 years of manufacturing experience (regulated environment, attention to detail and following detailed instruction).
- Knowledge of Good Manufacturing Practices c(GMP) and applicable Quality System Standards preferred.
- Willingness to work rotating shifts, weekends and overtime, as necessary.
- Effectively adjusts to changes and deals effectively with uncertainties in the workplace.
- Ability to generate new and valuable ideas and effective solutions to difficult problems; connects previously unrelated notions.
- Realizing the worth of all people and respects others, regardless of background or cultural differences.
- Thoroughly understanding the needs of internal/external customers and making customer satisfaction a top priority.
- Strong motivation and ability to achieve work goals and quantifiable business results.
- Ability and desire to cooperate, collaborate, and partner with others.
- Willingness to help outside your department and within your department outside your normal or assigned responsibilities.
- Demonstrated use of logical methods to solve problems with effective solutions and able to make quick quality decisions.
- Dedicated to providing the highest quality product and meeting the expectations and requirements of internal and external customers.
- Takes ownership and accountability for the production process, assigned production area, production equipment and associated documentation.
- Good interpersonal skills and ability to communicate information in a timely manner to those who need the information.
- Drive self and team to schedule adherence and most efficient production process.
- Uses his/her time effectively and efficiently; concentrates his/her efforts on the more important priorities for the department.
- Knows personal strengths, weaknesses, opportunities and limit; seeks feedback and open to criticism.
- Demonstrated willingness to be flexible and adaptable to the needs of the department and business.
- Enjoys the challenge of unfamiliar tasks.
- Consistently demonstrates the functional and technical knowledge and skills to do the job at a high level of accomplishment and proficiency.
- Possesses skills to develop, coach, and mentor others.
- Willing to take on challenges and stretch tasks.
- Understanding of the department and its functions.
- Candidate must be willing to wear a variety of personal protective equipment.
- 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 also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
- Must possess good hand-eye coordination.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer:
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.