Responsible for the design, development and enhancement of manufacturing processes.
The primary responsibilities of this role are the execution of equipment and process improvement projects, design, development or enhancement of new and existing products and processes and being a process owner. Enhancing process knowledge, technical problem solving and mentorship are major elements of this position. This positon will provide technical support to the manufacturing quality and regulatory functions for the operation of manufacturing processes.
Essential Duties and Responsibilities
- Utilize standard engineering principles to resolve difficult problems, from conception to final design with team input
- With minimal guidance, schedule and lead a team through the planning and execution of a medium sized project or defined piece of a larger project. This includes evaluation, selection and adaptation of various engineering techniques, constructing detailed, accurate project schedules, interfacing with development groups and technical support groups.
- Devise new approaches to complex problems through adaptations and modifications of standard technical principles.
- Supervises/coordinates an engineer/scientist and/or technicians and contractors on assigned work and projects.
- Lead technical problem solving for operational issues using engineering and scientific principles
- Perform equipment testing and commissioning, and support qualification activities as needed.
- Lead/participate in process equipment improvement projects. This consists of identification and implementation of equipment and process changes in adherence with industry standards and company quality systems.
- Create detailed and accurate project schedules and budgets in accordance with the approved scope. Interface and align with cross-functional groups. Remain accountable for projects timelines and spending. Identify and resolve issues that may jeopardize project schedules/scope/cost in a timely manner.
- Establish, develop and drive Good Engineering Practices and execute projects in accordance with the prescribed project management methodology.
- Draft regulatory submission for process changes.
- Strong process engineering skills based on sound engineering and scientific principles.
- Extensive technical expertise and strong working knowledge of other related disciplines of engineering common to the business.
- Must have excellent communication skills in order to effectively communicate with all levels of professionals, both internal and external.
- Demonstrated ability in technical writing, describing complex processes and qualifications.
- Able to convince management on courses of action with minimal assistance using both written and verbal methods.
- Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
- Effective team member with experience in handling multiple projects and leading cross-functional teams with minimal guidance.
- Able to prioritize multiple tasks
- Able to incorporate cGMP concepts, quality systems requirements and safety into process and equipment design.
- Must be able to provide solutions that reflect an understanding of business objectives and cost implications.
Education and/or experience
- BS in Engineering and 5+ years related experience required. MS in Engineering preferred. Demonstrated success in delivering results in several technical challenges, Experience in the biopharmaceutical manufacturing environment related to Engineering, Project Management and Validation. The candidate must have good communication skills and the ability to perform effectively in multi-disciplinary teams.
- Must be able to lift, push, pull and carry up to 25 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold, wet environment
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required (only for non-exempt positions).
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
Location/Region: Los Angeles, CA