Entry Level Computer Systems Validation Engineer

PSC Biotech is a leading process consulting and contract engineering company. For over 19 years we have been
engaged in providing laboratory support, project, process, engineering and
validation support to top:tier pharmaceutical and biotech companies.

We are looking for an Entry:Level
Computer System Validation Engineer. This role would
work alongside an amazingly talented PSC Team, and works under the leadership
of one of the best in the industry

Successful candidates will have
excellent verbal and written communication skills, an understanding of the IT
realm, and a thirst to learn

Responsibilities:

:

Provide
CSV authoring, review and approval of validation documents developed by
functional validation teams, ensuring the documentation meets regulatory
requirements and quality standards.
:

Initiate/update
GxP and Risk Assessments on system.
:

Author,
Review and or approve scheduled periodic reviews.
:

Author,
Initiate, and/or review and approve IT SOPs related to compliance
:

Collaborate
with project stakeholders and the information systems team to define needs
and achievable solutions and/or justifications to system
requirements
:

Draft
and execute computer system validation documentation

o

Validation Project Plan

o

Requirement Specification (URS, DS,
FS)

o

IQ and OQ Test Scripts

o

IQ/OQ/PQ Protocols, as necessary

o

Traceability Matrix (TMX)

o

System Release Memo

o

Validation Summary Report

:

Translate
system requirement specifications into executable validation
protocols
:

Provide support to executors of the protocols when
needed
:

Write reports summarizing system validation
Requirements

:

Bachelor's Degree in Chemical Engineering, Biomedical
Engineering, Computer Science or IT/IS from a 4 year University
:

Must
have strong written and verbal communication skills
:

Previous
experience in IT Industry is preferred
:

Previous
experience in GxP Industries are preferred
:

Must
be adaptable, customer service oriented, have a positive attitude
:

This
role requires additional hours worked. You must have a flexible schedule