The CSV Technical Leader main role is to :
- Be the Single Point Of Contact for any CSV related question
- Advice users, as well as clients representative when new computerized system are installed
- Coordinates activities with the help of users, IT and QA department.
- Translate user’s needs into technical solutions, taking into account QA requirements, as well as IT technical constraints.
- Ensure first line troubleshooting and support on CSV day to day activities
- Manage improvement/modifications to be performed on computerized systems, in close collaboration with users, QA and IT departments
- Ensure a techno-vigilance into his field of competencies
He/she is the Subject Matter Expert covering technical questions into his field of competencies (electronic data management, equipment qualification, data integrity, …).
He/she is the interface between the Technical Service department and all other MaSTherCell’s departments or customer for technical aspects related to projects he/she is leading.
He/she warns the Technical Service Supervisor / Manager in case of issue.
He/she manages the action log related to CSV activities he/she is leading and respects the timelines.
Organizes and manages regular meetings to ensure the follow-up of all tasks linked to CSV activities
Ensures respect of KPI.
For his/her direct responsibility, he/she ensures cGMP implementation through MTC’s quality system and feeds continuous quality improvement.
Supports change control preparation.
He/She Initiates and finalizes Deviations (Owner role) and CAPA for hierarchy approval.
He/She is trained for required activities and is providing data for relevant KPI.
Trends & continuous improvement:
He/she implements and follows-up Key Performance Indicators.
He/she implement pertinent tools of operational excellence “Lean culture”.
MUST HAVE REQUIREMENTS
- Master/Engineer in Science, electro-mechanical or equivalent by experience.
- At least 4 years experience in pharmaceutical field: ie 21CFR Part 11/ equipment quqlification / technical support / maintenance /validation / clean room / equipment management.
- Minimum 4 years experience in CSV.
- Fluency in French & English. Good reading comprehension and writing skills in English.
NICE TO HAVE REQUIREMENTS
- Computer skills: Microsoft office, expertise with GMAO tools database management tool.
- Efficient communicator and willing to bring new challenges.
- Demonstrated leadership and cross functional team spirit.
- Rigorous, conscientious, curious, versatile, open-minded & quality-minded.
- Customer oriented.
- Solutions & results oriented.
- Full-time position (40h/week).
- An Indeterminate contract.
- The opportunity to take part in a growing dynamic biotech company.
- A human-sized working environment with a convivial atmosphere.
The following languages are an exclusion factor, not meeting this criteria will automatically reject your application.
French - read C2 - write C2 - speak C2
English - read C1 - write C1 - speak C1
MINIMUM REQUIRED EDUCATION
REQUIRED EXPERIENCE IN YEARS
4 to 10 years