Job Title: Senior Manufacturing Engineer (Process Development)
Type: Contract
Pay: $60.00-$66.00/hr
Location: 1555 Adams Dr Ste A&B Bldg 17, Menlo Park, CA
We are seeking a Sr Manufacturing Engineer for a very important client.
Participate and contribute towards new product development of pharmaceutical drug product in support of company’s strategic plan. In this role, the candidate will be responsible for the overall operations and manufacturing engineering activities related to planning and execution of builds and experiments intended for product development, new process and equipment integrations, equipment qualification, validation master plan, process risk assessments etc.
Responsibilities may include the following and other duties may be assigned.
· Support development of Pharmaceutical Quality System from a Manufacturing Engineering Perspective
· Own/Coordinate overall Manufacturing activities for product development batches/builds
· Own initiation, execution, closure of build packets (engineering, qualification, and clinical batches)
· Own equipment qualification activities
· Own/Coordinate equipment maintenance and calibration activities with onsite maintenance group
· Collaborate with supply chain and manage materials issuance for development and clinical builds
· Support facility cleanroom qualification activities
· Support cleaning qualification activities
· Own/Support Master Validation Plans
· Ensure alignment between Operations and Core Team with a vision for long-term sustainable commercial manufacturing of the product
· Provide indirect people management including assemblers and technicians who conduct manufacturing operations for the builds
· Gather and manage manufacturing related requirements to ensure they meet project and timeline needs and collaborate with team members and key stakeholders
· Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
· Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
· Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
· Develops manufacturing processes that are applicable to statistical process control
· Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
· Ensures processes and procedures are in compliance with regulations.
HM's Top Needs:
1. Experience with Pharmaceutical Product manufacturing and pharmaceutical quality systems
2. Experience with new product and process development including equipment and process validations
3. Experience coordinating/leading manufacturing builds
Education Required:
Bachelor’s Degree in chemical engineering, biomedical engineering, or mechanical engineering
Years’ Experience Required:
Minimum of 5 years of relevant experience, or minimum of 3 years of relevant experience with an advanced degree
Must Have: Minimum Requirements
· Bachelor’s degree required in chemical engineering, biomedical engineering, or mechanical engineering
· 100% on-site presence required
· Requires a University Degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
· Experience with new product and process development including validations and commercial launch
· Experience working with biodegradable polymers and drug/device combination products (polymer-based combination drug products intended for sustained/controlled drug release).
· Drug coating processing experience (spray coating, dip coating) required.
· Excellent organizational and operational skills including attention to detail and documentation, the ability to learn quickly, and the ability to manage multiple projects and multiple tasks simultaneously.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
