Senior Process Engineer - (US-NC-Raleigh)
Senior Process Engineer - (US-NC-Raleigh)
Compensation: $75K - $100K / Year
Min Education: Bachelors
Job Type: Full Time
Jobcode: SPE-001BJAExperience Required : 5 - 10 years
Degree Required : 4 Year Degree
PAID RELOCATION AVAILABLE
Engineer responsible for design, engineering, equipment specifications, and technical execution of manufacturing and utility processes for the development of transgenic plant process systems used for the production of clinical materials and commercial quantities of human therapeutic proteins.
Essential Duties and Responsibilities:1. Lead and perform process design, specification, start-up and validation activities for process equipment and process utility systems in a GLP/GMP manufacturing environment. 2. Prepare technical documentation such as: Equipment and instrument specifications; FAT/SAT; Project schedules and budgets; Validation protocols; Instrument calibration/preventative maintenance plans ; Standard operating procedures in support of project activities. 3. Support manufacturing and maintenance personnel in the production of clinical materials by providing technical expertise for training, trouble shooting, corrective action and change control. 4. Support facility operations with project management activities as required for facility modifications, improvements, and manage small capital projects as required. 5. Ensure the compliance of clean room design and certification processes to current industry trends and company procedures. 6. Designs, develops, and analyzes large-scale production processes and/or systems. 7. Plans and develops estimates and/or budgets for technology transfer and to facilitate corporate planning. 8. Work proactively with other engineering functions, departments, and outside contractors to complete design and engineering projects within schedule, budget and quality restraints. 9. Develop/review Process Flow Diagrams (PFD) and Piping and Instrument Flow Diagrams (P&ID).
Qualifications: B.S. in engineering (chemical, biochemical, mechanical), or equivalent, with knowledge of biochemical and biological processing. Sr. Level requires a minimum of 10+ years of pharma/biotech experience (MS / PhD degrees may complement / supplement industry experience). Relevant GMP (regulated) industry experience in pharmaceutical and biotech processes - including process development, process engineering, upstream / downstream processing is a necessity. Good communication skills, both written and oral, and ability to work in a team environment as well as independently. Proficiency in MS Office Suite, Visio, and MS Project. AutoCAD experience a plus.
Candidate Must Have :
* High level team leadership responsibilities, including organizing, managing and directing efforts between internal project teams and consultants, engineering firms and contractors.
* B.S. in engineering (chemical, biochemical, mechanical), or equivalent, with knowledge of biochemical and biological processing.
* Sr. Level requires a minimum of 10+ years of pharma/biotech experience (MS / PhD degrees may complement / supplement industry experience).
Email resume in Word to thebiggamehunter@cisny.com. Please include the job code for the position with your resume.
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posted by Unknown at 5:21 PM
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