Job Description

Our site in Schachen is a 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, providing Biologics Drug Substance manufacturing for Clinical Supply.   Our site serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Schachen site, but that the facility belongs to and is shaped by them.     

As a Qualification and Computer System Validation (CSV) Senior Specialist, you will be part of the Technology Lifecycle Excellence (TLE) Team, responsible for ensuring the qualification of equipment and computer systems in compliance with regulatory requirements. Your role is critical in maintaining a state of permanent inspection readiness while optimizing processes for efficiency and compliance. You will act as an SME (Subject Matter Expert), lead small projects, and contribute to the continuous improvement of qualification and validation strategies at the site.
 

Key Responsibilities

Perform and document Equipment Qualification (EQ) and Computer System Validation (CSV) activities.Ensure compliance with regulatory requirements for Clean Air Systems (e.g., HVAC, isolators, LFHs) and computerized systems.Optimize qualification and validation processes, standardizing documentation for efficiency and compliance.Serve as the primary point of contact and SME for qualification and CSV, providing expert guidance to internal and external stakeholders.Lead small-scale qualification and CSV projects with a hands-on, results-driven approach.Mentor and train less experienced colleagues to strengthen expertise in qualification and validation.Ensure audit and inspection readiness, actively representing the qualification and CSV domain during regulatory inspections.Support root cause investigations and drive process improvements in response to deviations.

Your Profile

Required Qualifications:

Bachelor's degree (or higher) in Engineering, Life Sciences, Chemistry, or a related field.Minimum 7 years of experience in the pharmaceutical industry, including at least 5 years in Equipment Qualification and CSV.Strong expertise in Clean Air Systems (HVAC, isolators, LFHs).Extensive experience in auditing and compliance within the pharmaceutical sector.Excellent communication skills in English and German – ability to convey complex technical topics in a clear and engaging manner.Strong project management skills – ability to organize, prioritize, and deliver projects efficiently, utilizing relevant project management tools.
 

Preferred Qualifications:

Experience with Quality Change Management Systems.Expertise in Root Cause Analysis and Deviation Management.
 

Why Join our team in Schachen?
This role offers the opportunity to work in a highly advanced facility, collaborating with an experienced team and contributing to the evolution of qualification and validation processes. If you are looking for a challenging and impactful position, we would love to hear from you!

Current Employees apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/18/2025

*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.

Requisition ID:R338605