Validation and Qualification Engineer
vor 1 Monat
Job Description
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
For our site in Krems, we are currently looking for a:
Validation and Qualification Engineer (m/f/d)
Full-time, as soon as possible
Main Responsibilities:
Leading assigned Commissioning, Qualification and Validation (CQV) activities including but not limited to equipment, processes, cycles, sterilization, transport, etc.
Development and approval of CQV Plans and Reports.
Support equipment and systems owners by providing technical knowledge
Establish and/or participate in risk analysis and assessment to support CQV activities and change management
Support Change Management, Deviation Management, and CAPA Management process on site and timely closure of tasks from the aforementioned
Follow GMP, company, and local aregulations regarding safety and CQV activities
Potential to be a sub-system owner for qualification and validation topic
Support site CQV program by conducting periodic reviews, requalifications, Sanitization/Sterilization in Place (SIP) and Performance Qualifications (PQs), Commercial off-the-shelf (COTs), in addition to undertaking Subject Matter Expert responsibilities for specific topics
Work in an interdependent team and with stakeholders to ensure facility and equipment maintains qualified and validated status
Initiate and support continuous improvement activities within CQV and the site
Requirements:
Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, Engineering or comparable work experience
Work experience or theoretical knowledge in a Pharmaceutical Company preferably in Aseptic Processing operations.
Hands-On-Experience or knowledge of CQV, (Bio) Process Technology, Microbiology, Aseptic Processing Equipment Design
Experienced in or knowledge on the qualification and validation of cleanrooms, sterilization processes and aseptic process media simulation
Experience or knowledge in risk management, change management, deviations and CAPAs management
Energetic and enthusiastic team player with innovative mindset, strategic, analytical and problem-solving skills
Fluency in written and spoken German and English. Very good knowledge of MS-Office applications
We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 43.548,4- and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.
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:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/ARequisition ID:R273695
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