Computerized System Validation (CSV) Engineer - Biotech Job

Date: Mar 30, 2019

Location: Oss, NB, NL

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Requisition ID: QUA008215

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. For our Biotech organization in Oss we are currently hiring an:
 

Computerized System Validation (CSV) Engineer - Biotech


The organization
Quality Operations (around 100 people) at MSD Biotechnology Operations Oss has the following five sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents Hub. The Quality Department must ensure adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of products according to corporate policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring.
 
For more information about MSD Biotech, please watch the MSD Biotech Oss video  below.
https://www.youtube.com/watch?v=yzzdXlQNzYY
 

The Position
Reporting into the Laboratory Supervisor CoE the Quality Control Qualification Associate Specialist will be responsible as a technical reviewer/ approver for lab equipment qualification, maintenance and retirement documentation, including calibration and testing protocols of external parties guaranteeing compliance in our manufacturing division and  quality policies. He/ she will provide technical expertise in investment projects for laboratory equipment.and will be responsible for establishing the annual maintenance program. He/ she will act as an SME and participates in global projects for Data Integrity activities related to computerized and non-computerized lab equipment.
 
As part of the role the CSV Engineer (internal: Associate Specialist – Quality Control Qualification) will also be responsible for:
 
Input in Quality Strategy:
• Responsible as a technical reviewer/ approver for lab equipment qualification, maintenance and retirement documentation, including calibration and testing protocols of external parties guaranteeing compliance quality policies;
• Provides technical expertise in investment projects for laboratory equipment, including selection of vendors and their products, and actively participates in the purchasing decision and process;
• Has a good understanding of laboratory equipment Qualifications (SDLC/CSV)
• Acts as an SME and participates in global projects for Data Integrity activities related to computerized and non-computerized lab equipment;
• Execute System Administrator tasks according to procedures. 
• Maintains the QCB qualification planning;
• Responsible for providing technical expertise and performing review tasks related to GCM changes and ECM changes concerning lab equipment;
• Responsible for establishing the annual maintenance program in collaboration with internal and external parties, providing the technical information for contractual terms as needed;
• Participates in site and global quality improvement projects and acts as a point of contact and SME for lab equipment.
• Supports lab investigations process as needed;
• Technical approval of  purchase and qualification documentation of laboratory equipment in line with current quality directives; 
• Acts as a quality expert for laboratory instrument maintenance and automation.
 
Compliance:
• Participates in site audits, regulatory and corporate inspections including support to audit responses as required as a SME;
• Provides impact or gives concurrence for GCM changes, follow up on QNs and CAPAs.
 
Guidance:
• Participation in cross-functional/global teams;
• Actively pursues information from within the MSD network for best practices.
 
Problem solving:
Technical expertise, first and second line troubleshooting.
 
EHS (environment, health & safety) Responsibility:
• Responsible for active contribution to realization of corporate policy on safety, health and environment;
• Demonstrates personal commitment with respect to working safely, healthy and environmentally friendly.
Qualifications

• Vocational (MBO) / Bachelor (HBO) degree preferable in Biotechnology, Chemistry, or relevant field; 
• Relevant experience, preferably in pharmaceutical Quality Control and cGMP;
• Sound knowledge of equipment design and use;
• Knowledge and experience with automated ICT is mandatory. Must be proficient in Windows XP and Windows 7 environments;
• Knowledge of image and incremental backups, installation of patches and establishment of workarounds (mitigation of vulnerabilities) and mitigation laboratory equipment related ICT problems;
• Ability to write, review and provide ICT knowledge for test protocols;
• Knowledge of and experience with quality and compliance guidelines, cGMPs;
• Knowledge of industry guidance and respective regulations of Equipment Qualification and Maintenance, Validation, Quality Control, Quality (Management) Systems, Documentation and Change Controls;
• Technical knowledge in testing techniques and lab equipment;
• Technical Writing skills, Failure Mode & Effect Analysis (FMEA);
• Lean Six Sigma Yellow / Green belt certified;
• Effective project management planning skills and ability to communicate on prioritization and bring others on the same page;
• Computer literacy knowledge
• Ability to work under minimum supervision, team work oriented and and hands- on mentality;
• Strong focus on clients and end-user;
• Good communication skills, pro-active and flexible;
• Excellent interpersonal and communication skills (oral and written) in English and Dutch or willing to learn.


A good place to work
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.


Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 2
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Biotech, Developer, Manufacturing Engineer, Systems Engineer, Pharmaceutical, Science, Technology, Engineering

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