Senior CQV Engineer - Process (OSD)

Adryan; Neuenburg; Vor Ort; CHF 90’000 - 130’000; Vollzeit

Zusammenfassung

A leading company in the pharmaceutical sector is seeking a Senior CQV Engineer to manage commissioning and validation activities in their Oral Solid Dosage manufacturing facility. The role is critical for ensuring compliance with regulations and readiness of key processes. Candidates should have a solid background in CQV, with at least 8 years of experience, preferably in the pharmaceutical industry.

Qualifikationen

• Minimum 8 years of CQV experience.
• At least 5 years in the pharmaceutical industry.
• 3+ years specifically in Oral Solid Dosage forms.

Aufgaben

• Lead CQV activities for process equipment in OSD.
• Develop and execute CQV lifecycle documentation.
• Support regulatory inspections and internal audits.

Kenntnisse

Project Management

Communication

Troubleshooting

Ausbildung

Bachelor’s or Master’s degree in Chemical Engineering

Bachelor’s or Master’s degree in Mechanical Engineering

Bachelor’s or Master’s degree in Biochemical Engineering

Tools

Kneat

ValGenesis

Jobbeschreibung

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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