Validation and Qualification Engineer
vor 3 Wochen
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)
for a two year contract, 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 regulations 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
During the two-years, support the site in various aspects and topics within Qualification and Validation based on production needs.
Requirements:
Minimum 3 years experience in large-scale production qualification and validation (clean rooms, sterilization/sanitization processes, complex equipment like autoclaves, washing machines, clean and dirty utilities, or something similar).
Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, Engineering or comparable work experience
Fluency in written and spoken German and English. Very good knowledge of MS-Office applications
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 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
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 44.100,- 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:
Project Temps (Fixed Term)Relocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
07/17/2024*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:07/17/2024
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:R293804
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