Senior CQV Engineer Process Systems (OSD)
Senior CQV Engineer Process Systems (OSD)
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Job Title: Senior CQV Engineer – Process Systems (Oral Solid Dosage)
Location: Canton Neuchatel
Job Type: Contract
Duration: 6 months, with possible extension
Position Summary:
We are seeking a highly experienced Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation activities for Process Systems in a Oral Solid Dosage (OSD) pharmaceutical manufacturing facility. This role is critical to ensuring the readiness and compliance of key process equipment and systems in alignment with cGMP regulations, FDA/EMA guidelines, and project timelines.
Key Responsibilities:
* Lead and manage CQV activities for process equipment such as granulators, blenders, fluid bed dryers, tablet presses, coaters, and other OSD manufacturing systems.
* Develop, review, and execute CQV lifecycle documentation (URS, FS, DS, FAT, SAT, IQ, OQ).
* Ensure systems are designed and qualified in compliance with cGMP, FDA 21 CFR Part 11, ISPE Baseline Guides, and company validation standards.
* Collaborate closely with cross-functional teams including Engineering, Manufacturing, QA, QC, and Regulatory Affairs.
* Manage and coordinate with vendors and contractors to ensure proper execution and documentation of FAT/SAT and field CQV testing.
* Support equipment and utility integration into process workflows, including MES, SCADA, and automation interfaces.
* Provide technical leadership and mentorship to junior CQV staff and participate in project planning and scheduling.
* Identify and troubleshoot process validation issues and deviations; lead root cause investigations and implement CAPAs as needed.
* Maintain traceability matrices and ensure alignment with project design and user requirements throughout the lifecycle.
* Support regulatory inspections and internal audits by providing technical documentation and subject matter expertise.
Qualifications:
* Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering, or a related discipline.
* Minimum 8 years of CQV experience, with at least 5 years in the pharmaceutical industry and 3+ years specifically in Oral Solid Dosage forms.
* Proven expertise in qualifying OSD equipment and systems, including cleaning validation and process validation protocols.
* Solid understanding of GAMP 5, ASTM E2500, and risk-based validation approaches.
* Strong project management and communication skills; ability to work independently and within cross-functional teams.
* Familiarity with regulatory requirements from FDA, EMA, and ICH guidelines.
* Experience with electronic validation tools (e.g., Kneat, ValGenesis) is a plus.
Please submit your resume in Word Document
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Engineering and Project Management
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