Cleaning validation

Title: Cleaning Validation Engineer

Location: Swiftwater, PA

Duration: Long-term contract

Mainly M-F with some flexibility in working hours. Will work some form of 8 hours within 7am and 5pm. Manager flexible. Prefer new hire to be open to very occasional weekend work or overtime if needed. May also need to switch a shift from morning to afternoon here and there. Hybrid - will usually be 4 days onsite and one remote but manager prefers flexibility just in case they are needed onsite the extra day.

MUST HAVE:

BS/MS degree

2+ years strong experience in cleaning validation in the Pharma biologics or vaccine industry

Experience in authoring, reviewing, executing and approving validation documents. (e.g. testing methods, protocols, reports)

Ability to develop cleaning cycle and lead the investigation or trouble shooting.

Strong root cause analysis with cGMP experience.

Ability to review and analyze data.

Cleaning Validation experience such as:

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

EXCELLENT communication skills

Ability to manage, execute and troubleshoot on their own

Strong Microsoft Suite skills (Word, Excel, Project, Outlook)

Strong Microsoft Suite skill

Experience participating in teams and collaborative work environments.

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