Equipment Validation Specialist - Randstad

An Equipment Validation Specialist is needed for a Swiss multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, in the Portsmouth, NH area. The Equipment Validation Specialist ensures GMP equipment and systems are validated, maintained, and compliant with regulatory standards by executing validation protocols, supporting quality systems, and driving process improvements in a biopharmaceutical manufacturing environment.

education: Bachelors

responsibilities:

• Act as a Subject Matter Expert (SME) for Quality Control, Manufacturing, and other departments.
• Own and drive validation plans and execution of equipment changes/process improvements.
• Perform Installation Qualifications (IQ), Operational Qualifications (OQ), and draft Performance Qualifications (PQ).
• Maintain GMP equipment in a validated state through validation maintenance quality systems and requalification activities.
• Manage and maintain validation equipment and supplies (e.g., dataloggers, probes).
• Develop validation protocols based on engineering documents.
• Provide technical support for reviewing and approving SOPs, Protocols, Change Controls, Deviations, and CAPA.

Skills:

• Learns from experiences, errors, and setbacks.
• Challenges the status quo, drives changes, and implements improvements.
• Works cross-functionally, shares knowledge, and values diverse perspectives.
• Uses business knowledge to make timely, effective decisions.
• Quality control, manufacturing operations, and equipment validation.
• MS Project, Word, Excel, PowerPoint.

Education and Experience:

• Bachelor's degree in a science-related discipline or relevant industry experience.
• 5-10 years in equipment validation, quality, or biopharmaceutical manufacturing.

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qualifications:

• Experience level: Experienced
• Education: Bachelors

• Validation
• Compliance
• Quality
• Regulatory
• Technical Writing

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.