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Specialist, Engineering
vor 1 Woche
Job Description
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.An exciting opportunity for an experienced Specialist Engineer to join our team has arisen working at our Werthenstein, Lucerne, Switzerland.Responsibilities:- Executing daily operations in the manufacturing of mAb in Fed-Batch and Continuous
Mode with initial focus in downstream processing. - Ensure full support to Good Manufacturing Practice (GMP) Drug Substance Fed-Batch Manufacturing (Operations Tier 1 Team) to seamless share resources to allow business continuity.
- Maintain GMP status of process equipment and areas by conducing routine monitoring, calibration, maintenance, certifications as needed.
- Perform investigations, root cause analysis and risk assessment to support deviations and change controls.
- Establish and maintain departmental procedures and practices to ensure efficient operation and continuous improvement, GMP documentation such as Standard Operating Procedure (SOPs), Batch Records, Sampling Plans, Qualification and Validation Protocols.
- Implement new technologies with software and instruments that can simplify and reduce effort around manufacturing and administrative processes.
- Assure the highest Quality, Compliance and Safety standards.
- Support Weekend or On Call duty on select time frames to support manufacturing.
- Inspire Diversity and Inclusion – building effective working relationship within a cross-functional team across different cultures and backgrounds.
- Embody Safe by Choice and know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals.
- Bachelor’s degree in Biology, Chemistry, Automation or Process Engineering, or another relevant discipline.
- Familiarity with Unit Operations for mAb manufacturing.
- Professional experiences with downstream processing such as Chromatography Steps and Ultra-/Diafiltration in a highly regulated industry is a strong asset.
- Proven understanding of Automation of manufacturing processes preferably on Delta V Platform
- Competent in analysing complex situations and show practical problem-solving capabilities.
- Oral and written communication skills in English (B1) would be must and German would be desirable.
- Ability to work independently and within a cross-functional team.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
07/10/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:07/10/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R296528
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