Handary is a specialist in natural shelf life solutions. Currently, we are looking for a Bioprocess Engineer experienced in Biologics and working in the fermentation plant.
* The Bioprocess Engineer is responsible for site based engineering support for cGMP fermentation / purification.
* Support / lead the design and specification of cGMP equipment, processes and utilities for biologics.
* Create and review project documentations.
* Create and review process models and sizing calculations for process equipment, control valves and etc.
* Manage and populate equipment lists and equipment data sheets.
* Liaise with client end user groups to ensure correct specification of equipment and utilities.
* Create Technical Specification and Functional Specification for automated and manual equipment
* Specify requirements for tanks, valves, pumps, fermenters, centrifuges (disctack and OR tubular bowl), HPLC, GC and high pressure homogenizer
* Sizing and specification of clean utility systems; RODI, PW, WFI, Clean Steam, Clean Compressed Air
* Provide engineering expertise and drive technical decisions as active member
* Perform HAZOP's and risk assessment to ensure safe / compliant designs
* Master’s degree in (Bio)chemical Engineering. Experience in cleanroom environment is a plus.
* Knowledge of food and pharmaceutical technology.
* Knowledge of cGMP procedures and HACCP.
* Familiarity with engineering project management
*Experience with high pressure homogenizers, centrifuges (disctack and OR tubular bowl), and anti-cellular antibodies.
* Understanding of Fermentation, Cell Culture, Centrifugation, Chromatography, Tangential Filtration Flow (TFF), CIP, SIP, IQ, OQ, and Clean Utilities
* Industry experience related to cGMP drug manufacturing, validation, and chemical process design
* Knowledge of computerized scheduling and spreadsheet software, planning and organizational skills.
* Excellent communication skills in English, good organizational skills.
* A detail-oriented team-player with strong problem solving skills.
Annual Gross salary: €40,000 +
Holiday: 20 days
Qualified candidates must submit a resume, in Word or PDF format, along with a compelling cover letter that describes your interest in the position and why you think you would be a good fit for the job. Applications should be sent to: firstname.lastname@example.org
EOE STATEMENT We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, age, national origin, disability, military status, genetic information, sexual orientation, or other applicable protected classes.
Reference no: EU103