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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: Expert Validation and Qualification (m/f/d)
Full-time, as soon as possible
Main Responsibilities:
- Plan, prepare and execute qualification and re-qualification activities of large-scale equipment and processes within GMP production and engineering areas – including development and approval of plans and reports
- Coordination of necessary activities for qualification with other team members and stakeholders (Quality, Production, Engineering).
- Creating, updating, and reviewing relevant SOPs and other documents.
- Commissioning, Qualification, Validation participation in capital projects as expert for qualification topics
- Contact person for all qualification related topics during internal and external inspections
- Creating and assessing change control requests and deviations
Requirements:
- Degree in technical or scientific area or equivalent work experience
- Multiple years of experience in qualification and validation
- GMP experience
- Fluency in English and German
- Experience or knowledge in problem solving and root cause analysis
We are looking forward to receiving your application.
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: RegularRelocation: Domestic
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 09/25/2024
- 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:09/25/2024
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:R311877