MSAT Engineer II
Company Background
My client is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in the RTP area, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. The company is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
The MSAT Engineer 2 will support the development and execution of product lifecycle management and process analytics activities with limited supervision and guidance. This role will collaborate effectively with personnel in Process Development, Manufacturing, Engineering, Quality Assurance, and Quality Control and utilize strong communication, technical expertise and influencing skills to generate optimal results.
This position reports to Director, MSAT
Major Accountabilities
- Provides advanced level support execution and development of the manufacturing control strategy and Process Analytics program and other functions as needed
- Acquires, analyzes, and reports data trends using graphical and statistical methods and utilizes advanced expertise to make recommendations to next level management based on data analysis
- Provides advanced support technology transfer and process validation of products that are complex in nature or scope into commercial manufacturing
- Independently authors standard operating procedures, reports, and protocols and solicit next level manager approval for final documents
- Builds on advanced technical expertise to begin to become viewed as a technical expert on the HAV manufacturing process, systems, and equipment
- Independently supports troubleshooting, non-conformance investigation, and change control management activities utilizing advanced engineering concepts and practices
- Independently develops and implements (following appropriate change control) process specifications, parameters, operating ranges, and action limits.
- Provides guidance to others on advanced and/or moderately complex theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift
- Other duties, as assigned
Special Competencies
- Able to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies
- Possesses advanced knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
- Possesses understanding and demonstrated knowledge of equipment and procedures and identifies potential problem before they occur
- Advanced knowledge of statistical process control charts and data interpretation
- Demonstrated technical foundation of cell- and tissue- based products and a familiarity with GMP manufacturing
- Demonstrated depth of understanding and expertise with technical and engineering operations of scaled cell culture systems. Experience with automated and online monitored systems highly preferred.
- Demonstrated depth of understanding and expertise with technical with feedback control and monitoring of relevant process gasses, nutrients, biological waste products in mammalian cell systems
- Independently and creatively develops solutions and implement process improvements to manufacturing issues by way of corrective and preventative actions (CAPAs)
- Highly motivated and organized
- Familiarity and understanding of foundational and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment. Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
General Competencies
- Able to communicate effectively in English, both verbally and in writing
- Possess a positive roll-up-the-sleeves attitude and optimistic outlook
- Represents the organization in a positive and professional manner
- Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
- Excellent organizational and time management skills with ability to set own priorities in a timely manner
- High degree of flexibility and adaptability
- Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
- Must be able to work as needed to meet tight deadlines and at peak periods
- Self-motivated and organized critical thinker with solid interpersonal and business communication skills
- Demonstrated ability to work in a cross functional team
- Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
- Always observe safety precautions and regulations in all areas where duties are performed
- Responsible for reporting all safety hazards and potential unsafe working conditions
- Reports to work on time and as scheduled
Qualifications
- BS in engineering or relevant field, required
- Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, and/or cell biology
- 2-5 years working in a GMP regulated environment
- Scaled cell culture processes experience
- Experience with Process Validation and Continued Process Verification (CPV)
- Experience with application of statistics to in-process measurements of biological systems in a controlled production environment
- Experience with cell culture operations, specifically using adherent mammalian cells
- Cell biology competence/background and tissue culture development experience, highly preferred
- Understanding and technical competence with mass transfer and gas transfer characteristics, fluid handling/mechanics and aseptic manufacturing