Do you want to work at one of the largest industrial pharma concerns in the Netherlands within a high-tech environment and use your knowledge and skills? Did you always want to work in a company where your work can have a real impact on people’s lives? We would like to meet you!
We have an exciting new job opportunity at our location in Oss and are looking to hire a
Purpose of the role
The purpose of the role as Site Cleaning Validation Subject Matter Experts is to maintain, further develop the execution of a validation program for Cleaning-In-Place and Cleaning-out-of-Place of process equipment and utensils.
The validation approach must be compliant with our companies’ global policies, procedures and guidelines, regulatory requirements and according CGMP in the performance of day-to-day activities. The validation activities are planned and executed by production department. The role is positioned in Center of Excellence Biotech Technical Operations. You will work closely together with quality operations and the integrated process teams.
Welcome in our team
The Center of Excellence Biotech Technical Operations in Oss gives technical support, process support, troubleshooting and continuous improvement to the local Biotech upstream and downstream production of commercial products and is involved in introduction of new biologicals in the manufacturing facilities. Biotech Technical Operations consists of approximately 50 members, with expertise in a variety of topics like microbiology, cell culture, purification, engineering, small-scale laboratory operations and validation of process and equipment. Biotech Technical Operations collaborates with global technical groups and our companies’ manufacturing sites across the network.
Specific accountabilities and responsibilities include, but are not limited to:
- Accountable for compliance of the site strategy to the global guidelines and regulatory expectations.
- Responsible and accountable of cleaning validation plan, (local) SOP’s on cleaning validation and cleaning validation quality risk assessments.
- Accountable for monitoring the cleaning validation status on site.
- Be point of contact regarding cleaning validation for the cleaning validation Center of Practice, and for the IPTs.
- Drive a deep understanding of the importance of compliance, considering an impact on EHS, GMP and regulatory requirements in all cleaning validation-related decisions made. Having knowledge and understanding of regulatory requirements within European and International codes, standards and practices.
- Develop, implement and ensure effective execution of the site cleaning (re-)validation program. Manage and perform data analysis to enable informed decisions/recommendations for achieving reliable supply of commercial products.
- Monitor periodic assessment timelines and results and monitor site validation metrics to site quality council.
- Assess process, equipment, utility and/or facility changes for cleaning validation impact.
- Driving improvements in cleaning validation methods and strategy and ensuring site wide implementation of the proposed improvements.
- Develop soil characterization and studies, swab recovery testing, review and approve cleaning validation protocols and reports. Set up protocols for visual inspection of equipment.
- Participate as SME during Pre-Approval Inspections, GMP inspections from Health Authorities and internal audits.
- MSc degree in life sciences (Biotechnology or related) or comparable level through experience.
- Minimum of 3 years of experience in biologic manufacturing.
- Knowledge of CGMP guidelines and regulatory validation expectations.
- Team player with ability to work in a multidisciplinary setting.
- Must demonstrate personal commitment with respect to inclusion, working safely, healthy and environmentally friendly and all other guidelines.
- Customer focused, process oriented and data driven.
- Experience with lean problem-solving methodologies and strong analytical
- Dutch (preferred) and English communication skills, verbally and written.
- Experience in the field of cleaning validation is preferred.
What we offer
We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.
- Competitive salary and a 3% year-end allowance.
- 35,5 days of leave.
- Attractive collective health care insurance package with considerable reduction rates.
- Solid Pension Plan.
- Annual bonus based on own and company performance.
- Travel allowance for commuting.
- Numerous training, coaching and e-learning modules for long term job opportunities and development.
If you like what you read, but not matching on all points. Please still apply, we would like to meet you!
Who we are … For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for … Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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.
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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.
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Requisition ID: R264243