Job Seekers, Please send resumes to resumes@hireitpeople.com

Must Have: 

Develops validation/qualification deliverables such as Validation Plans, RequirementsSpecifications, 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 plusAdvanced 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 requiredMinimum of 5 years’ experience performing/supporting activities in a GMP environment.Minimum of 3 years’ experience in equipment, facility or utility qualification