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Commissionning and Qualification Pharmaceutical Sector [F/M/X]

MANTU GROUP SA, Sauk Trail Beach, WI, United States


Commissionning and Qualification Pharmaceutical Sector [F/M/X] Permanent Job

Commissioning and Qualification Specialist

- We are looking for a skilled professional to join our dynamic team in the pharmaceuticals sector. The ideal candidate will have a minimum of 4 years of experience in the commissioning and qualification of critical equipment, including HVAC systems and clean rooms. This role is essential in ensuring that our facilities meet the highest standards of compliance and operational efficiency.

Key Responsibilities

Lead the commissioning and qualification processes for HVAC systems and clean rooms in compliance with industry regulations and company standards.

Develop and execute validation protocols, including IQ, OQ, and PQ documentation.

Collaborate with engineering, operations, and quality assurance teams to ensure seamless project execution.

Conduct risk assessments and provide recommendations for improvements in systems and processes.

Maintain accurate records and documentation of all commissioning and qualification activities.

Stay updated on industry trends, regulations, and best practices related to commissioning and qualification.

Qualifications

Bachelor’s degree in Engineering, Life Sciences, or a related field.

Minimum of 4 years of experience in the pharmaceutical sector, specifically in commissioning and qualification of HVAC systems and clean rooms.

Strong knowledge of regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, ISO).

Excellent problem‑solving skills and attention to detail.

Strong communication and interpersonal skills, with the ability to work collaboratively in a team environment.

What We Offer

Competitive salary and performance‑based incentives.

Comprehensive benefits package, including health insurance, retirement plans, and paid time off.

Opportunities for professional development and career advancement.

A collaborative and innovative work environment.

Amaris Consulting is proud to be an equal‑opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

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