Beschreibung
CQV Lead Bioconjugation(m/f/d):The CQV Lead Bioconjugation is primarily responsible for the preparation and the execution of the CQV activities relating to Bioconjugation Process Equipment.
Main responsibilities
- Self-manage CQ development and execution activities with respect to the relevant systems.
- Function as a key member of the CQ Team, and provide guidance regarding Bioconjugation Systems.
- Maintain control over the activities and schedule with respect to the relevant systems.
- Participate in sessions to define/agree work breakdown structure with respect to the relevant systems
- Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.
- Coordination and communication with other resources for Bioconjugation Systems-related matters.
- Adherence to project procedures/requirements with respect to Health/Safety/Environmental, Quality (including GDP/GMP), CQ (including MCP, MQP, DQ, IQ, OQ, Commissioning).
- Liaise closely with the relevant vendors/providers/contractors, project Automation representatives and Construction-phase representatives to ensure integration of activities and schedules with respect to the relevant systems.
- Actively participate in the development and delivery of deliverables with respect to the relevant systems.
- Report on key deliverable and dates and align with key milestones within the project's critical path.
- Report and aid in the resolution of project issues, including maintaining the non-conformance records.
- Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.
- Prioritize and execute tasks in a fast-paced environment.
Profile:
Minimum requirements:
- Minimum Bachelor's degree in Life Sciences or Engineering
- Minimum of 6+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.
- Proven Bioconjugation system knowledge.
- Minimum 6+ years of experience in commissioning / qualification / validation of Downstream systems.
- Experience with DeltaV (Emerson).
- Fluent English language written and verbal communication skills.
- cGMP knowledge and knowledge of regulatory requirements.
- Able to work with minimum oversight fulfilling deliverables within target dates.
Preferred requirements:
- Fluent German is a distinct preference.
- Experience with COMOS/KNEAT platforms.
- Biopharmaceutical knowledge.
Project details
Start Date: ASAP
Duration: 12 months (option for a contract extension)
Location: Southern Switzerland
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.