Sr. CSV & (C&Q) Specialist

Overview:
Mentor Technical Group (MTG) provides specialized technical support and solutions for FDA-regulated industries. MTG is recognized for its expertise in life sciences engineering, ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy standards. Resources considered for this RFP will support pharmaceutical manufacturing operations and must meet the following minimum qualifications.

Responsibilities:

• Support Commissioning and Qualification (C&Q) activities for plants and equipment.

• Develop, review, and maintain commissioning and qualification procedures and documentation.

• Write, review, and approve C&Q protocols and reports for various systems, including HVAC, utilities, production equipment, and lab equipment.

• Execute commissioning and qualification activities and coordinate with internal teams and external consultants to ensure timely delivery.

• Manage change controls and deviations related to plants and equipment.

• Support maintenance and calibration functions to improve compliance and quality.

• Provide expertise in troubleshooting and root cause investigations.

• Facilitate the transfer of technical knowledge across units and sites.

Qualifications / Requirements / Knowledge / Skills:

• Proven background in pharmaceutical product manufacturing, specifically in sterile packaging operations.

• Demonstrated experience in Commissioning and Qualification (C&Q) activities.

• Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements.

• More than 5 years of experience in Equipment and Computer System Validation within pharmaceutical facilities.

• Experience with digital validation solutions (e.g., ALM or equivalent).

• Excellent skills in writing validation, commissioning, and technical documentation in English.

• Proficient in MS Office applications (Word, Excel, PowerPoint, etc.).

• Bilingual: fluent in English and Spanish.