Agency:
Job Title:
Description:
PSC Biotech
Entry Level Validation Engineer
Validation Engineer Intern/Entry-Level candidate wanted to train on
GMP facilities and cGMP requirements. In addition, applicant will be
trained on writing technical reports, and Validator Software. Intern
will gain hands on experience in all areas of validation. Applicant will
be working in a biotech/pharmaceutical environment as a
consultant/contractor for various clients. He/she will be working
closely with client's employees on various projects and various GMP
facilities to help client with validation issues. Applicant must be
willing to learn new ideas, techniques and systems. Applicant must
be willing to commute to clients' manufacturing sites.•Assist in
preparing and reviewing Validation Life Cycle documentation:
Validation Plans, User Requirements Specification, Impact
Assessments, Design Specifications, Design Qualification,
Installations Qualifications, Operational Qualifications, User
Acceptance Testing, Performance Qualifications, Process Validation
protocols.•Assist in executing validation protocols (DQ, IQ, OQ, UAT,
PQ & PVs).•Assist in preparing and reviewing Summary
Reports.•Assist in performing 21 CFR Part 11 assessments required
for 21 CFR Part 11 regulations.•Assist in preparing and reviewing
protocol deviations. Perform system trouble shooting.•Ensure all
validation documentation is in compliance with Corporate policies,
local policies /SOPs and regulatory standards such as Annex 11,
Annex 15, 21 CFR Part 11, cGMP, cGAMP, GDP, ICH.•Assist in
preparing and reviewing validation SOPs and work
instructions•Collaboration with cross functional teams including;
Project Engineers, Project Managers, Quality Representative and
Compliance Representative and Operational Representative.•Review
and modify Standard Operating Procedures (SOPs)•Generate test
procedures to validate new or previously unvalidated
equipment/processes•Participate in and conduct any or all of the
following types of validation: ◦Cleaning Validation◦Process
Validation◦Computer Validation◦Equipment Validation◦SIP/CIP
Validation◦Risk Assessments
Location:
Waco, TX
Qualifications: •Applicant must have graduated with or pursing an engineering or
technical degree from a four-year college or university•Knowledge on
regulatory/compliance/validation issues, self-motivated, intelligent
and reliable a plus but not required•Knowledge of PC computer OS
(typically Windows), knowledge of Word and excel are
mandatory.•Must have strong written and oral communication skills
and organizational skills•Possess self-motivation and
drive•Experience in writing technical documents, especially
compliance and/or Validation/quality assurance documents and
protocols will be desired.•Applicant must also be willing to perform
more sophisticated/complicated types of validation work.•Must be
flexible and able to manage multiple priorities simultaneously
Link:
email to pschr@biotech.com
Contact:
Sarah Mckibben
Phone:
(909) 784-3350
Email:
pschr@biotech.com