Physical Requirements (Due to the nature of the job):
- The candidate should be able to lift 25 pounds with assistance.
- Ability to sit, stand, walk and move within workspace for extended periods.
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
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.
Must Haves:
- BS in Engineering or Science related discipline required.
- 5 years' experience performing/supporting activities in a GMP environment.
- 3 years' experience in equipment, facility or utility qualification.
Environmental Conditions:
- Primarily an office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
- Ability to work safely and effectively when working alone, or working with others.