Minimum Requirement:
Education background/ Experience: BSc in relevant technical field or equivalent level through education, training, and experience in Pharmaceutical Validation.
Several years of experience in a technical or quality role in highly regulated industry such as pharmaceutical industry
Knowledgeable in the areas of responsibility; Process, Equipment Engineering, Automation
Knowledge of Fill-Finish/Freeze Dryer/Autoclave desirable
Positive attitude, can-do mentality
Self-initiative, independent and goal-oriented way of working
Flexibility, critical judgement, resilience, and reliability
Culturally savvy, demonstrated team building capabilities
Experienced in a Biotech/ Biopharma/ cGMP environment
Special Knowledge:
SPS!!!!
cGMP
Computer literacy
Skills:
Good leadership and coaching skills
Good language skills in German and English, both in oral and written communication
Good communication and social skills
Good presentation skills
Good planning and organization skills
Good knowledge and experience in EH&S
Good knowledge and experience in facilities for pharmaceutical manufacturing.
List Responsibilities And Job Duties:
Technical operational and engineering support for the sterile production facility
Provide leadership and direction to the extended engineering team (Plant-, Process- and Automation Engineers)
Ensure resources to projects and initiatives, oversee the work of the team.
Ensure planning and implementation of the required maintenance and improvement activities.
Support and contribute to the shutdown planning for the manufacturing site.
Determination and assessment of measures (KPIs) to ensure high technical availability of the production facilities
Supporting the operation in measures to improve processes and increase efficiency
Support audits at the Facility and associate Compliance/Safety programs.
Point of contact for Engineering & Automation related queries.
Manage all Engineering & Automation contracts and contractors.
Liaise with Support / Maintenance contractors.
Identify, build, and implement Engineering & Automation systems training across site.
Complete assigned training - and identify gaps /opportunities for further training.
Develops and champions continuous improvement programs that increase performance and reliability.
Develops mechanisms for monitoring, trending, and reporting performance.
Provide SME insight and technical leadership to the engineering, production, and support areas.
Conduct analysis of Bad Actors and drive a program to improve.
Management and Control of associated site Engineering & Automation Budgets.
Support Engineering Projects, Validation, Warehouse, QC/QA, Operations, and other departments.
Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up related CAPA's.
Foster Deviation investigations within the department. Use Lean Six Sigma tools to drive root cause analysis and CAPA completion.
Ensure compliance with Safety, Quality, Environmental Regulatory and Corporate requirements.
Support safety and environmental programs. Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
Perform all duties in accordance with cGMP requirements, SOPs, and controlled documents.
Flexibility to take on additional tasks and responsibilities at the discretion of the Site Engineering Head.
