Automation CSV Lead

2 months ago


New Brunswick, United States Pharmatek Consulting Inc Full time

The Automation/CSV Lead will manage the qualification of automation systems including DeltaV BMS BAS and EMS as well as CSV for production equipment and ytical instruments. This role requires a deep understanding of automated control systems and experience in computerized systems validation (CSV).


Key Responsibilities:

Develop and execute protocols for automation systems including DeltaV BMS BAS and EMS.

Perform CSV for production equipment and ytical instruments.

Collaborate with engineering and CQV teams to align automation validation activities with project timelines.

Conduct risk essments and implement mitigation strategies for computerized systems.

Oversee doentation lifecycle for CSV activities ensuring compliance with regulatory standards.



Requirements

Qualifications:

Bachelor s degree in Computer Science Engineering or a related field.

10 years of experience in automation and CSV within the pharmaceutical industry.

Expertise in DeltaV Building Management Systems (BMS) BAS and Environmental Monitoring Systems (EMS).

Strong knowledge of GAMP5 FDA regulations and 21 CFR Part 11.

Excellent technical doentation and project management ss.



At least 3 years experience/ knowledge with automated systems, including programming and improving complex systems Familiarity with at least one computer coding language (such as Python, Java, C#, HTML), understanding in version control systems (like GitHub or GitLab) is a plus Able to independently contribute through development and optimization of automation technologies preferred. Able to oversee implementation of automation technologies with third parties through technical ss and project management principles Must be able to work productively in an interdisciplinary team environment Experience with Hamilton, Scinomix, Tecan or similar automated laboratory platforms preferred Good oral and written communication, problem-solving, and ytical ss Ability to influence and educate other scientists and engineers to use automation technologies as part of implementation Proficiency using PC and Microsoft Office tools Excellent organizational and time management ss Strong attention to detail GMP and Good Doentation Practice Intermediate ss with WORD (authoring/editing large technical doents with styles, tables, TOCs, track changes) Basic ss with EXCEL and PowerPoint Experience with and tolerance for high levels of challenge and change Experience with project management including capturing project requirements and deliverables, timeline development, stakeholder management and communications
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