Cleaning tech specialist [Netherlands]

 

Job Description

For our Biotech organisation in Oss (The Netherlands) we are currently recruiting a:

Cleaning Validation Engineer – Downstream Processing

About us

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We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The department

Biotech is located in Oss, where over 500 employees work in the biotechnological production. Within our department novel biologic active ingredients (“Drug Substance”) are manufactured, including medicines for fertility and oncology. We have global partners in the U.S., Europe and Asia Pacific to ensure medicines are delivered in a safe, reliable and cost-effective way.

Within Biotech in Oss, there are two Integrated Product Teams (IPTs) – responsible for Upstream Processing (USP) and Downstream Processing (DSP) operations. The active ingredients produced in USP are purified in DSP to pure Drug Substance. Our clean room facilities are 24/7 operated to provide treatment to patients globally. The DSP IPT supports the manufacturing of both licensed commercial biologic products as well as new novel biologic products being developed to meet un-met medical needs.

Welcome in our team

The role of Cleaning Validation Engineer is situated in the Process Support team of IPT DSP. Process Support is responsible for (Master) Manufacturing and Cleaning documentation, shopfloor support and first-line trouble-shooting. The team of about 18 people consists of Biotech Specialists (two sub-teams with different product-focus, fertility and oncology), (Cleaning) Validation engineers and an MES (PAS-X) engineer.

Primary tasks/ responsibilities

The Cleaning Validation Engineer reports into the Process Support Lead. Together with your direct colleague, and in cooperation with the Technical Unit and QA, you are responsible for all activities in the IPT related to Cleaning Validation:

• Writing and reviewing cleaning verification, (re)validation and annual assessment protocols and reports, and ensuring these comply with our global cleaning policies, procedures and guidelines and external regulatory requirements;
• Planning and coordinating execution of (annual) cleaning validation activities together with operations and scheduling;
• Writing and maintaining of Master Cleaning batch records;
• Coordinate and author cleaning related events (deviations), including performing impact assessment, root cause analysis, CAPA development/implementation;
• Organizing, performing and reporting annual / baseline visual inspections of product contact equipment;
• Providing technical and hands-on support towards Operations with regard to cleaning processes and cleaning validation activities;
• Supporting cleaning development, e.g. soil characterization, swab recovery testing;
• Driving improvements in cleaning (validation) processes and leading efforts in completing the intended improvements.
• Depending on department needs and your experience, the role may include above responsibilities for sterilization (validation) for autoclave or hot air sterilizers.

Qualifications

• Minimum BSc (required)/MSc (preferred) in life sciences (Biotechnology, Food processing or related field) or comparable level of practical experience;
• Minimum of 2 (required) or 3-5 (preferred) years of experience in Biotech Processing or strongly related field;
• Experience with writing of technical (validation) documents (highly preferable);
• Knowledge of, or experience with writing of, electronic Master Batch records and automation recipes (e.g. in MES/PAS-X, Unicorn, PCS) (preferable);
• Experience in Root Cause Analysis and facilitate Lean Six Sigma tools (preferable);
• Experience with deviation management and change control (preferable);
• Strong project management skills (preferable);
• Team-player, self-starter and customer focused, able to build and maintain strong relationship with multiple groups;
• Process oriented and data driven;
• Go to gemba mentality and practice;
• Proficient in cGMP’s and EHS as it applies to pharmaceutical industry;
• Excellent verbal and written communication skills in both Dutch and English.

For more information about the Biotech department, please watch our video below.

https://www.youtube.com/watch?v=yzzdXlQNzYY

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R239779

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