Materials and Cleaning Validation Senior Specialist (m/f/d)

Job Description

Our Company`s Schachen site serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives.

Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them.

The Biotech facility, at Schachen, state-of-the-art facility that enables and advances our best work.

By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions.

Scachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.

The Materials and Cleaning Validation Senior Specialist is responsible for supporting the cleaning validation and Single Use Technology activities, ensuring compliance with internal standards, regulatory requirements, and industry best practices.

The role contributes to the development, execution, and maintenance of validation documentation, technical assessments, and risk-based solutions, while supporting the introduction of new products, equipment, and processes.

Working closely with cross-functional partners, the Senior Specialist helps maintain robust, reliable, and efficient manufacturing operations.

• Cleaning Validation and Sterilization
• Lead the site cleaning validation program and support the development, update, and execution of cleaning validation documentation, including protocols, reports, studies, and risk assessments.
• Design and improve cleaning procedures for new products, new equipment, and manufacturing processes, including clean-in-place practices where applicable.
• Support timely introduction of NPI and new equipment into the validation program through technical assessment, planning, and execution.
• Review and approve cleaning-related working instructions, forms, and change controls.
• Investigate cleaning-related incidents, deviations, and out-of-specification results, including root cause analysis and troubleshooting.
• Support periodic review of cleaning validation studies and ensure timely resolution and closure of cleaning-related incidents and deviations.
• Train manufacturing, QC, and QA personnel on cleaning validation documentation, procedures, and compliance requirements.
• Prepare for and support internal and external audits and inspections related to cleaning validation.
• Single Use Technology
• Contribute to the development and execution of the site Single Use Technology strategy in close collaboration with Technology& Engineering, Technology Strategy, Operations and Quality.
• Develop and maintain Single Use Technology flow diagrams, process closure requirements, and design standards to ensure consistency across the site.
• Standardize materials of construction, sizes, and connector types to reduce complexity and support supply chain resilience.
• Support facility design reviews, vendor collaboration, and development of component-level specifications and drawings.
• Maintain the Single Use Technology database and manage design changes throughout the project lifecycle.
• Facilitate stakeholder workshops to define process requirements and support approval of Single Use Technology specifications.
• Identify SUT requirements to support commissioning, qualification, verification, procurement, and project schedule adherence.
• Support SUT change management, root cause investigations, and closure of corrective and preventive actions.
• Coordinate and track Extractable & Leachable assessments and ensure vendor data is available and reviewed in line with project timelines.
• Review and approve SUT risk assessments, calculations, and reports.

Required Education, Experience and Skills

• Bachelor’s degree (B.

S.) or equivalent in biology, chemical engineering, or a related discipline with at least 6 years or master’s degree (M.

S.) with at least 4 years previous experience in a relevant position in GMP manufacturing in the pharmaceutical or biotech industry

• Minimum 3 years of experience in cleaning validation within a GMP-regulated environment
• Strong understanding of cleaning chemistry, residue limits, analytical methods, and equipment design
• Knowledge of applicable regulatory guidance (FDA, EMA, PIC/S, ISPE, etc.)
• Excellent analytical skills, and detail orientate
• Working knowledge of c GMP regulations
• Demonstrated supervisory and leadership skills
• Excellent oral / written communication skills in English (C1)

Required Skills

• Adaptability
• Adaptability
• Analytical Testing
• Change Request Management
• Chemical Engineering
• Cleaning Validations
• Cross-Functional Collaboration
• Data Analysis
• Detail-Oriented
• Deviation Management
• Equipment Qualification
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Manufacturing Processes
• New Product Development
• Preventive Action
• Process Design
• Process Hazard Analysis (PHA)
• Process Optimization
• Regulatory Requirements
• Risk Assessments
• Root Cause Analysis (RCA)
• Strategic Collaborations
• Strategic Thinking
• Technical Leadership
• Employee
• Status: Regular
• Relocation: No relocation VISA Sponsorship: No
• Travel

Requirements: 10% Flexible

• Work
• Arrangements: Not
• Applicable
• Valid
• Driving
• License: No Hazardous Material(s): N/A Job
• Posting
• End

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century.

Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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