Beschreibung
TätigkeitenbeschreibungFür unseren Kunden in Schaffhausen (CH) suchen wir einen freiberuflichen
BTO - Cleaning Validation Engineer (m/w)
Aufgaben / Responsibilities:
The Cleaning Validation Engineer will be accountable for cleaning validation of technology transfers and legacy biologic, non-biologic and solid dosage form products.
• Cleaning validation expertise
• Technical support for cleaning validation
• Enhance reliability, compliance & efficiency of product value chains end to end
• Integrate Manufacturing Operations and Pharmaceutical Development in partnership with Product and Customer Management
PRINCIPAL RESPONSIBILITIES:
• Write/ review cleaning validation protocols/reports
• Coordinate and execute risk and gap assessments, define actions and ensure follow-up
• Support of Cleaning Validation Life Cycle Management
• Validate Manufacturing Process and Cleaning Capability/Quality/Cost Improvement Changes
• Provide technical assessments to Change Controls/CAPA’s and Deviations
• Drive system improvement activities
Anforderungen / Qualifications:
- University/Master Degree in Chemistry or Pharmacy or Equivalent;
- solid experience in Cleaning Validation
- at least 2 years related experience in the pharmaceutical sector overall with past proven field experience in the following areas:
o Experience in Drug Product Manufacturing Process and Cleaning Requirements/Techniques
o Experience in cross-contamination risk assessment tools
o Ability to operate in a complex global matrix organization with multiple stakeholders
o Knowledge of Quality Assurance and Regulatory Compliance cGMP and EH&S
o Knowledge of the latest legislation updates with focus cross-contamination
• Fluent in both English and German
Projektstart:
- 01.10.2015
Dauer:
- 30.09.2016 (100%, fulltime vor Ort)
Einsatzort:
- Schaffhausen (CH)
Haben Sie Interesse? Bitte senden Sie uns Ihr englischsprachiges Profil inklusive einer Angabe zum Stundensatz für Schaffhausen (CH) (bitte all-in) an
Wir melden uns in Kürze bei Ihnen zurück.
Vielen Dank!
Fähigkeiten (Must have)
cleaning, Validation