- Gardena, CA, United States
The Mechanical Engineer should have experience in the pharmaceutical/biopharma industry as well as hands on experience working in a cGMP facility. Experience developing and implementing designs for cleanroom environments and HVAC/mechanical systems. Basic knowledge of system and building controls. Experience with lean methodologies for better flow and efficiencies across the entire value stream.
Specific responsibilities include:
- Manage the implementation of projects from concept development to project completion
- Executes complex assignments requiring the use of advanced techniques, resulting in the development of new or improved processes, equipment and/or technological methods
- Be the liaison between any applicable contractor and the company for new equipment implementation, working in close cooperation with the Operations team, for design work or other support functions performed by an outside firm.
- Utilize cGMP experience to streamline processes while meeting all regulatory requirements
- Develop standardized operating instructions, performance standards and Standard Operating Procedures for all Operations processes
- Establish and maintain effective relationships with the many support groups within the organization to obtain timely input of their requirements into the projects and their assistance in project execution.
- Provide management with updated analysis and projections on the status of process operations projects focusing on management of change, schedule compliance, cost control and major project highlights in a timely manner.
- Perform other related duties as assigned
This position has no direct supervisory responsibilities but is required to influence and lead cross functional Project teams.
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE:
- A Bachelor’s Degree from an accredited four year college or University in Mechanical or Chemical Engineering, Master’s Degree preferred.
- 4-6 years’ experience in Mechanical Engineering with proven results in a manufacturing engineering setting.
- Lean Six Sigma Certification is preferred
- Experience with auotcad or other design software
- Effective communication, interpersonal skills with leadership ability and a good team player.
- Experience in process driven operations; chemical down packing experience highly desirable.
- Strong technical knowledge and ability in process engineering disciplines.
- Solid knowledge of cGMP, FDA and other applicable regulations.
- Demonstrated history of identifying and implementing process operations improvements that resulted in significant gains in operational efficiencies.
- Knowledge of process automation, programmable logic controllers, power systems, and controls highly desirable.
- Knowledge of federal and state health and safety regulation
- Strong understanding of statistical concepts/methods, as well as process optimization techniques (i.e. waste elimination, parts flow, pull, etc.) as well as Lean Six Sigma methodologies.
- Proven project management skills and expertise
- Solid organizational skills including attention to detail and multitasking skills
- PMP certification preferred
Tuesday, October 4, 2022