Validation Engineer

Vertragsart:
Vor Ort
Start:
10.2013
Dauer:
3 Monate
Von:
C&M Consulting and more AG
Ort:
Zug
Eingestellt:
25.09.2013
Land:
flag_no Schweiz
Projekt-ID:
603610

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Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
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MANUFACTURING ENGINEER VALIDATION

GENERIC DESCRIPTION
To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of the company’s Validation Policies and Procedures are addressed. Primary Tasks and Responsibilities ? Managing Complexity/Technical Accountability serves as technical expert for the Validation process and responsibilities to ensure compliance ? Continuous Learning/Managing Risk ? Resolves & manages technical operational problems in area of expertise ? Suggest and sometimes may implement innovation and continuous improvement within the Validation process ? Implements initiatives in the Validation Process that will deliver customer value at lowest cost. ? Facilitates successful team behaviour within Quality Systems and across functional areas ? Manages relationships externally and internally. ? Builds cross-functional and cross-departmental support, fostering overall effectiveness ? Fosters harmony within Quality Systems. ? Influences and persuades so as to bring about technical and process improvements. ? Ensure accuracy and maintenance of the company Validation Master List. ? Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise. ? Ensure all validation activities and documents are authorized and appropriate compliance approval is gained. ? Ensure that all validation activities are carried out and reported in a timely manner. ? Ensure compliance through assisting in audits. ? Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with company Policies and Procedures. ?Facilitates, encourage and coordinate continuous improvement with respect to validation activities. ?Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment ?Lead by example, inculcating the Credo values in all actions within the workplace Technical Profile Requirements ? Knowledge of bespoke validation. ? Process knowledge and documentation. Desirable: ?In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry ?High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations. ?Working experience of validation computer systems for use in a FDA regulated environment. Non-Technical Profile Requirements ?Must be able to lead and give direction to Validation Projects and Teams. ?Individual must also be an active team member in Validation activities Methodology/Certification Requirements ?

SPECIFIC DESCRIPTION :

As a part of the global remediation quality plan (GRQP) to support the plant specific activities with investigations and remediation

Active in the plant specific Q- Organisation (Switzerland/ Austria/Germany)

Experience in Process Validation, Medical Devices, Mechanical and Chemical Processes, 21 FDA 820

Knowledge & Skills:
Required degree/certificates:
Junior Engineer or Technician

Specific technical skills (please detail):
21 FDA 820
ISO 13485

Specific knowledge for the role (please detail):
Good documentation practice

Specific languages:
German - good understanding / English fluent

Competencies:
Familiar with international dealing Companies (Matrix-Organization)
Intercompany Traveling (D-A_CH)

Experience:
Medical Device is plus

PLEASE NOTE THAT THIS ROLE IS BASED ON DIFFERENT SITES:

Balsthal/SO
Bettlach/SO
Grenchen/SO
Hägendorf/SO
Langendorf/SO
Mezzovico/TI
Oberdorf/BL
Raron/VS
Waldenburg/BL

THANK YOU FOR MENTIONING ON THE TEMPLATE WHICH LOCATION(S) THE PROPOSAL SHOULD BE CONSIDERED FOR.

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C&M Consulting and more AG,
Steinengraben 18
CH-4051 Basel
Tel.