The Flex Team Engineer is responsible for supporting and leading operations projects, improving productivity, yield, and velocity, as well as providing training and leadership to other technicians. In certain cases they will be asked to support Manufacturing operations by utilizing Quality System and process documentation in the production of finished goods, in a cGMP environment.
Key Objectives of the role:
Assists in the designs, evaluation, implementation, and maintenance of production standards to ensure product quality and compliance with regulatory requirements.
- Works with members of the conversion team to create and/or modify a variety of methods, procedures, and work instructions to ensure that appropriate processes are developed, tests are conducted, and that products, materials, and manufacturing equipment meet required standards.
- Performs elementary statistical analysis to analyze trends, and works with the conversion team to investigate trends, conduct root cause analysis and recommend and implement corrective actions for processes.
- Assures compliance to in-house and/or external specifications to standards, such as cGMPs and ISO regulations.
- Address and resolve basic conversion related issues using real time engineering, quality, and lean principles and techniques.
- Interfaces and collaborates with other departments to coordinate process development and improvement.
- Generates and communicates elementary technical documents, procedures, standards and guidelines
- Calibrate/operate semi-automated and automated manufacturing equipment.
- Execute on the job training of other team members as required.
- Coach others on procedures, team work, etc, and lead by example, exemplify positive behavior.
- Assign resources when and where necessary to ensure production schedule is attained.
- Identify opportunities and implement productivity improvements.
- Maintain equipment and rooms in proper operational condition
- Maintain records to comply with regulatory requirements, GMP’s and standard operating procedures.
- Monitor and ensure all personnel are following safe practices and SOP’s.
- Develop and maintain proficiency in all value stream related manufacturing departments
- Perform activities in controlled environment up to and including classified clean room conditions.
- Perform in-process testing to assure batches meet specification.
- Perform manufacture of cell culture products in accordance to current good manufacturing practices.
- Support and initiate quality, safety, compliance improvement initiatives.
- Weigh, measure and check raw materials to assure batches manufactured contain proper materials and quantities.
- Comply with all company safety regulations and procedures.
- May be required to perform other related duties as required and/or assigned
Nature and Scope:
Works on assignments that are complex in nature where judgment is required in resolving problems and making routine recommendations. Normally receives no instruction on routine work and minimal instruction on new assignments. May determine methods and procedures on new assignments and may lead other non-exempt personnel.
Associate degree in a scientific or technical discipline or the equivalent knowledge and experience required.
Bachelor’s degree in Biology, Chemistry, or Engineering preferred.
Requires a minimum of 4 years experience in a GMP manufacturing environment, 2 years experience in a GMP manufacturing environment with an Bachelors degree, or equivalent knowledge and experience.
Demonstrated leadership capabilities are preferred.
Knowledge of computer applications and current software is desirable.
General understanding of machinery and mechanics.
Has contact with Leadership team, Engineering, manufacturing team members, direct supervisor and various levels of internal customers. May have contact with external customers and suppliers.
Working Conditions:Works mainly in a manufacturing environment; is required to lift up to 45 lbs. and may be required to stand for long periods of time while performing duties. Must be able to work safely