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.

Our Schachen site serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them.

The Biotech facility, at our Schachen site, is a state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Our Company’s Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.

The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for Technology Transfer and Facility Fit will enable the facility to adapt in a flexible and agile way for rapid product launch.

The Specialist Engineering will be a member of the Solution Supply Team within Drug Substance Support Operations at our Schachen Site. This position must be physically on site to support the team and its activities. The Specialist Engineering, Solution Supply has a variety of key responsibilities.

Responsibilities:

• Supporting in daily operations in the Solution Supply team: weighing and dispensing of raw material, preparation and dispensing of cell culture media and buffer used in the fed-batch and continuous manufacturing of m Ab.
  
• Operation review of executed Batch Documentation
  
• Ensure full support to Good Manufacturing Practice (GMP) Drug Substance Manufacturing 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, Buffer Memo, 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.
  
• 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.
  
• Developing future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.
  
• Championing Ways of Working around Operational Excellence as well as EHS requirements via Gemba and tools like Enablon, with the aim of building and maintain a strong EHS culture.
  
• Collaborating across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally.
  

Your Profile:

• Bachelor’s degree in Biotechnology, Chemistry, Process Engineering, or another relevant discipline.
  
• Or an apprenticeship in a relevant field with over 5 years of industry experience.
  
• Professional GMP experiences in the pharmaceutical or biotech industry is a strong asset.
  
• Familiar with Single use systems in Bioprocess.
  
• Experience with quality management and compliance systems and in writing quality records.
  
• Competent in analyzing complex situations and show practical problem-solving capabilities.
  
• Oral and written communication skills in English and German.
  
• Ability to work independently and within a cross-functional team.
  
• Strong technical writing abilities.
  
• Competent in analyzing complex situations and showing practical problem-solving capabilities, with a desire to continuously learn, improve and develop.
  
• Delta V and MES (Manufacturing Execution System) knowledge and experience is an advantage.
  

THE COMPANY
Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

Our Werthenstein Bio Pharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
Yes
Job Posting End Date:
12/4/2024

• 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:R320440