MSD Validation Qualification Engineer m/f/d 

Austria, Lower Austria 

761378368

Job Description

Main Responsibilities:

• Leading assigned Commissioning, Qualification and Validation (CQV) activities including but not limited to equipment, processes, cycles, sterilization, transport, etc.

• Development and approval of CQV Plans and Reports.

• Support equipment and systems owners by providing technical knowledge

• Establish and/or participate in risk analysis and assessment to support CQV activities and change management

• Support Change Management, Deviation Management, and CAPA Management process on site and timely closure of tasks from the aforementioned

• Follow GMP, company, and local regulations regarding safety and CQV activities

• Potential to be a sub-system owner for qualification and validation topic

• Support site CQV program by conducting periodic reviews, requalifications,Sanitization/Sterilizationin Place (SIP) and Performance Qualifications (PQs), Commercial off-the-shelf (COTs), in addition to undertaking Subject Matter Expert responsibilities for specific topics

• Work in an interdependent team and with stakeholders to ensure facility and equipment maintains qualified and validated status

• Initiate and support continuous improvement activities within CQV and the site

• During the two-years, support the site in various aspects and topics within Qualification and Validation based on production needs.

Requirements:

• Minimum 3 years experience in large-scale production qualification and validation (clean rooms,sterilization/sanitizationprocesses, complex equipment like autoclaves, washing machines, clean and dirty utilities, or something similar).

• Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, Engineering or comparable work experience

• Fluency in written and spoken German and English. Very good knowledge of MS-Office applications

• Work experience or theoretical knowledge in a Pharmaceutical Company preferably in Aseptic Processing operations

• Hands-On-Experience or knowledge of CQV, (Bio) Process Technology, Microbiology, Aseptic Processing Equipment Design

• Experienced in or knowledge on the qualification and validation of sterilization processes and aseptic process media simulation

• Experience or knowledge in risk management, change management, deviations and CAPAs management

• Energetic and enthusiastic team player with innovative mindset, strategic, analytical and problem-solving skills

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR46.305,0and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

Current Contingent Workers apply

Project Temps (Fixed Term)

Not ApplicableNot Indicated

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.