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 cGMP 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 {+ 2 more}

Preferred Skills:

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Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/26/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.