What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares & Life Sciences?
Roles & Responsibilities:
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 multitasking 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
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 multitasking 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
