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Must Have: 

• Develops validation/qualification deliverables such as Validation Plans, Requirements
• Specifications, Traceability Matrices, Summary Reports, Change Controls.

Knowledge, Skills, and Abilities:

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Experience in the qualification of cell therapy equipment a plus
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
• Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi?tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.

Education and Experience:

• BS in Engineering or Science related discipline required
• Minimum of 5 years’ experience performing/supporting activities in a GMP environment.
• Minimum of 3 years’ experience in equipment, facility or utility qualification