Specialist Microbiology

Job Description

Do you want to work for one of the largest industrial and pharmaceutical group in the Netherlands within a high-tech environment and use your knowledge and skills to produce products that matter and saves lives?

For our location in Oss Biotech we are looking for a Specialist Microbiology.

The role:

The specialist microbiology (senior improvement engineer) contamination control (CC) is responsible for deviation management, change control management, problem solving, improvement initiatives, day-to-day troubleshooting and periodic trend reports related to contamination control. The Specialist Microbiology participates as team member in cleanroom control/EM related project teams to provide contamination control information and documentation where required. Documentation is kept up-to-date and compliant with the cGMP & EHS requirements.

EM = environmental monitoring

UM = Utility Monitoring

IPT = Integrated Process Teams (departments)

Organization and the team:

In total, around 320 employees work at the Biotech organization (BT) that consists of an Upstream processing (USP) department, downstream processing (DSP) department, and external warehouse. USP is located at three sites (Building BF, HF & FB), DSP is in one building (BE). Strict cGMP and EHS guidelines apply for both departments to prevent product/environmental contamination, guarantee compliance and to create a safe work environment for employees. The contamination control team (CCT) is responsible for routine environmental monitoring (REM), process environmental monitoring (PEM), water/steam (Utilities monitoring, UM) monitoring, EM data management, cleaning & disinfection program and the gowning regime.

The team consist of 7 members with different backgrounds an expertise + the manager.

Responsibilities:

• The Contamination and Control Team (CCT) representative in project teams for process transfers related to EM/UM/contamination control/cleanroom control.
• Write or review EM/UM/contamination control/cleanroom control related documents in accordance with the related chapter and implement approved changes in process documentation.
• Ensure timely availability of documents (e.g. logsheets, procedures, etc)
• Ensure that EM/UM sampling/cleanroom control activities are correctly introduced.
• Review user requirements for assets
• Review documents for TechOps & M&R for the relevant chapters
• Supports and manages the EM/UM activities/programs in cleanrooms on a daily basis, including continuous improvement of those.
• Perform cleanroom control related facility fit studies in close collaboration with Tech-Ops / SCM, e.g. smoke studies
• Preparation and implementation of PQ documents
• Standardization of the monitoring process in close collaboration with EM samplers
• Part of review team for quality risk assessment (QRA) related to cleanroom control.
• Review sampling plan & specifications related to monitoring.
• Consultant role related to EM/UM/contamination control for other IPT.
• Initiate and lead complex improvement projects and 8-step problem solvings for the IPT/CoE
• Standardize & simplify EM/UM/contamination control/cleanroom control related work to minimize variation.
• Write or modify SOP’s/CJA’s/OJT’s for the IPT
• Maintain current knowledge of regulatory and industry standards, trends and advancements in EM/UM/contamination control/cleanroom control.
• Write or review A3 proposals for IPT/CoE related processes to improve performance (compliance, financial, robustness, safety)

Change management

• Initiate and implement EM/UM/contamination control related changes in close collaboration with TechOps & IPT departments.
• Task and change owner in GCM for EM/UM/contamination control related changes
• Gives CCT related input for impact assessment on changes from other departments.

Deviation management

• Create, coordinate and resolve Quality Notifications (events) related to EM and UM excursions.
• Define and implement corrective and preventive actions.
• Assess deviations in EM/UM/contamination control/cleanroom control applying problem solving tools and Root Cause analysis.
• Deviation coordinator in the deviation control system, responsible for timely follow-up and defining appropriate corrective and preventive actions.

Trouble shooting & Problem Solving

• Responsible for first line troubleshooting regarding microbiological issues/topics
• Act as team leader/facilitator in problem solving using the 8-step process or equivalent.
• Coach personnel in problem solving.

GMP, EHS guidance

• Participate in (site) projects to improve EHS or cGMP practices.
• SME in safety studies for hazardous processes in the IPT/ CoE related to EM/UM/contamination control/cleanroom control.
• Comply with GMP and EHS requirements.

Audits & Inspections

• Participate in (external) audits or inspections.
• SME for EM & UM processes

Your profile:

• Microbiology/Biotechnnology/Bioprocess technology at Bachelor/Master level with at least 3 years of relevant experience in (bio)chemical manufacturing under cGMP rules or proven Bachelor/Master thinking level with more than 5 years of experience
• Basic microbiological knowledge
• Proven ability to manage projects
• Certified problem solver
• Passion for Lean and continuous improvement
• Excellent communication in English and Dutch.

We offer:

Working at our organization means working together on health in an international working environment with dedicated colleagues. You will be given all the space you need to develop yourself and show who you are. You can also count on attractive terms of employment:

• A competitive salary.
• 35.5 vacation days.
• 8% holiday allowance and 3% end-of-year bonus.
• Annual Incentive Plan (7%)
• An excellent pension.
• Various training modules.

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID: R284410