Permanent

Senior SME Aseptic Process

SalaryCompetitive
LocationLeverkusen, Germany
SectorGeneral

Description

Job Title: Senior SME aseptic processes


Job Summary


Reporting to the Head of production management DP7, the senior SME will initially be responsible for supporting activities to ensure the facility and process design meets end user requirements. The senior SME will provide expertise in writing/reviewing SOPs, Batch Records, Deviations, and other technical documents as it relates to the Fill Finish Operation. In this the senior SME ensures compliance with GMP regulations by strict adherence to departmental policies and procedures and timely accurate completion of records as needed. This role supports management in development of improved and new processing techniques in the various aseptic processing activities and provides technical support to production staff involved in the various aseptic processes. The senior SME is responsible and proficient in initiation, execution or support quality processes (Deviation, CAPA and CCR) in QMR TrackWise. In audits the senior SME answers process related inquiries into process related topics.

Essential Duties and Responsibilities


Leadership & People Management
• You will part of a team of experts with different fields of expertise and responsibilities. In this you will bring your professional know-how into the team and devise as part of the team improvement of established processes or implementation of new processes.
• Work effectively with QA/QC, manufacturing, facilities and other support staff personnel
• Provide the aseptic/process training to floor operation personnel
• Support or lead Tech transfer projects from receiving site.
• Responsible to support the training coordinator.
• Perform process mapping and process efficiency trending
• Determine KPIs

Safety Culture
• Designs processes according to EHS principles.
• Actively participates in risk assessments as required.
Compliance
• Comply with GMP regulations by strict adherence to departmental policies and procedures and timely accurate completion of records as needed.
• Troubleshooting and technical support into process investigations.
• Facilitate deviation initiation , be responsible to investigate the issue, propose and execute CAPA.
• Facilitate/responsible of the change control process.
• Owner process related BR incl. improvement – support PDM at CCR´s and adjustment MBR
• Responsible for process related topics in audits
• Support validation and engineering project as production final user
• Support batch record review

Person Specification
Technical Competencies
• Professional experience in pharmaceutical production, at least 5 years required
• Vocational training on pharmaceuticals or chemistry or comparable training
• Seek opportunities for Continuous Improvement through the use of Lean/Six Sigma tools (Standard Work, TPM, 5S, Method 1, 2 etc.)


Knowledge
• Familiar with the design, development and improvements of APS strategies.
• Strong knowledge on aseptic working technics at isolator and RABS systems.
• Knowledge in the areas of GMP and occupational safety
• Familiar to sterile preparation production meeting cGMP
• Detailed knowledge on FDA and EMA guidelines for aseptic manufacturing in fill and finish environments
• Able to communicate in German and English

 

Qualifications
• Bachelor’s degree in the life sciences, or completed professional training at the pharmaceutical/medical/chemical/biopharmaceutical industry and several years of professional experience at the pharmaceutical/medical/chemical/biopharmaceutical industry are required
• Professional experience in pharmaceutical production, at least 5 years required at fill and finish manufacturing (RABS or Isolator technology, small/mid size scales)

Behavioral Competencies
• Team work capability with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude.
• Excellent verbal and written communication and presentation skills.
• Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation.
• High degree of autonomy, initiative, dynamism and goal-oriented functioning
• Results oriented, with the ability to manage multiple priorities in a short period of time.
• High degree of flexibility and resilience to answer to needs of a dynamic production process and demands of stakeholders (internal and external)
• Detail-oriented organizational skill

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