QUALITY ENGINEER: Job Code D-01
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RESPONSIBILITIES: As a Quality Engineer your role could include one or more of the following; pre-production quality assurance and design control, ongoing support of manufacturing operations, supplier quality and quality systems. You will support product development teams, write design and process FMEAs, design, write, and implement validation protocols, participate in internal and vendor audits, develop Manufacturing Quality plans, perform product and process evaluations to develop, recommend and implement improvements.
QUALIFICATIONS: To qualify, you must have a 4-year technical degree and at least 5 to 7 years of experience in medical devices or related field. Specific experience should include participation on development teams, supplier quality and manufacturing support including: FMEAs, validations, DOEs and extensive process development, monitoring and statistical controls. ASQ CQE certification is strongly preferred. Excellent written and verbal communication skills are required to write quality plans, validation protocols and reports, design history file and communicate effectively with team members, physicians and management.
YES - there is an opportunity for a QUALITY ASSURANCE MANAGER as well should your experience meet that level.
ASSOCIATE DIRECTOR PROCESS DEVELOPMENT: Job Code D-03
RESPONSIBILITIES: Reporting to the Sr. Director of Process Development and directly supervising 2 Managers you will be directing the development, planning and implementation of product and process development for new products and technologies from the laboratory through pilot plant and into manufacturing scale. You will also provide strategic direction, tactical oversight and technical expertise for all activities within the Product/Process Development area. Additionally, the qualified candidate will be expected to formulate and recommends manufacturing policies and programs to maximize yields and reduce costs.
EXPERIENCE: PhD in Chemistry, Biochemical Engineering, Biochemistry, or a related discipline with 7-10 years in all aspects of process/product development, or BS/MS degree with 10-12 years of relevant experience. Experience with cGMP, GLP, process development/scale-up and methods/process validation is required. Your technical experience should be primarily in protein purification process development; cell culture experience would be a plus. You should also have previous staff management responsibilities.
MANUFACTURING ASSOCIATE: Job Code D-04
RESPONSIBILITIES: Perform a variety of cell culture manufacturing tasks in accordance with cGMPs. You will performs some or all of the following in strict accordance with Standard Operating Procedures (SOPs): tissue culture, preparation of bulk solutions, large scale bioreactor operations and aseptic manipulation of cell cultures. Assists in the implementation of production procedures to optimize manufacturing processes. Participate in authoring documentation for manufacturing operations.
QUALIFICATIONS: BS in Biology or related life science and a minimum of 2-3 years experience. Detailed knowledge of mammalian cell culture systems and familiarity with regulatory (GMP's) and Standard Operating Procedures will be required.
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