Engineer 4, Industrial Manufacturing - JJJP00012419

작업 내용

We are looking for a Manufacturing Engineer/ Senior Scientist for the Discovery, Product Development & Supply (DPDS) Department located in Schaffhausen, Switzerland. The resource will be responsible mainly for Technology Transfers.In this position, you will establish Manufacturing Science and Technology expertiseacross different equipment platforms for drug product development & manufacturingwith focus on Parenterals. You will represent the DPDS Clinical Supply Chain pilotplant in development and clinical/commercial supply teams ensuring timely clinicalsupplies for drug product.Responsibilities

• Ensure timely plant readiness to support experimental / clinical activities.
• Ensure timely delivery of clinical material from internal pilot plants.
• Provide pilot plant input & requirements to Drug Product Development (DPD) /

Primary Container Development (PCD).

• Support scale-up and Tech-Transfer.
• Acts as the tech transfer receiving party for pilot plants.
• Put relevant manufacturing information and technical capabilities in place for

the operations team to flawlessly produce the DP according to GxP, EHS andbusiness requirements.

• Responsible for the electronic master batch records for new products using

the site MES system.

• Ensures that manufacturing processes are consistent with agreed platforms

and are scalable and transferable to commercial operations.

• Review qualification documents, calibration, deviation handling and COC.

Spokesperson during audits and inspections.

• Supports investigations, CAPAs, change controls according to assigned

responsibilities and performs critical raw data review for key documents

• Specialist for technology platforms being used within the Pilot Plant & across

network

• Assess new technologies / applications: feasibility, business case, conceptual

design, installation and implementation

• Actively participates in individual or team-based scientific development

activities and collaborate in internal / external scientific communities.

• You have a degree in Pharmaceutical/Biochemical/Chemical or relevant

Sciences or comparable experience in pharmaceuticals or in a related fieldwith demonstrated ability (5 years) OR a PhD with proven experience (3years).

• Demonstrated proficiency and experience in biologics drug product

development within the biopharmaceutical industry is helpful.

• Demonstrated proficiency and experience of biopharmaceutical process

design is helpful.

• Solid understanding and experience of technology transfer operations is

preferred.

• Solid understanding and experience in fill/finish operations is preferred.
• Proven track record of creativity and problem solving.
• Ability to collaborate with cross-functional teams is a must.
• Excellent oral and written language skills in German and English.

Please note that you must be eligible to work in Switzerland.If you are interested, or you know anyone that might be interested, please contact me at mpoenaru@actalentservices.com.Job Title: Engineer 4, Industrial Manufacturing - JJJP00012419Location: Schaffhausen, SwitzerlandRate/Salary: 70.00 - 95.00 CHF MonthlyJob Type: ContractTrading as Aerotek and Actalent Services. Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom. No. 2876353. Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield