USA-Validation Specialist III (Engineering)

Post Date

Mar 23, 2023

Location

Swiftwater,
Pennsylvania

ZIP/Postal Code

18370

Job Type

Contract

Job Description

Job Title: Validation Specialist III

Duties

Experience in cleaning validation in the biologics or vaccine industry to include the following:
o Experience in authoring reviewing executing and approving validation documents
o Interface with Quality organization and the ability to defend rationale in validation documents
o Ability to develop cleaning cycle and lead the investigation or trouble shooting
o Ability to review and analyze data

Cleaning Validation experience
o Acceptance criteria determination
o Sampling plans and sample size determination
o Rinse and Swab sampling experience
o Bracketing and worse case rating
o QC testing requirements
o Dirty hold times and clean hold times

Basic Qualifications:

Experience utilizing Microsoft Word Excel and Outlook

Experience writing and revising documents e.g. testing methods protocols reports

Experience performing testing in a GMP setting

MS Project experience

Skills

Proficiency in utilizing documentation system to author protocols and reports

Experience participating in teams and collaborative work environments.

Good communication skills verbal and written math skills general computer skills

Team environment a must

E Doc/GEODE experience with a working knowledge of templates workflows and approval process

Strong root cause analysis with cGMP experience.

Education

BS/MS in Science e.g. Chemistry Biochemistry Analytical Chemistry or Engineering Chemical or Biochemical with 2 total years of experience working in a biologic vaccine or pharma industry

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.