Job Posting for Validation Engineer (Cleaning Validation) at SGS Consulting
Job Details
Job Description:
Experience in cleaning validation in the biologics or vaccine industry to include the following:
Experience in authoring, reviewing, executing, and approving validation documents.
Interface with Quality organization and the ability to defend rationale in validation documents.
Ability to develop cleaning cycle and lead the investigation or trouble shooting.
Ability to review and analyze data.
Cleaning Validation experience:
Acceptance criteria determination
Sampling plans and sample size determination
Rinse and Swab sampling experience.
Bracketing and worse case rating
QC testing requirements
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.
Comment:
Mainly Monday Friday 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.
Start ASAP with possibility to extend after December 2024.
Mostly hybrid - will usually be 4 days onsite and one remote but manager prefers flexibility just in case they are needed onsite the extra day.
Minimum 1-3 years validation experience, open to more experience within rate range.
No degree requirements but bonus if related.
Must have:
Cleaning Validation experience
strong communication skills
Ability to manage, execute and troubleshoot on their own.
Strong Microsoft Suite skills
Salary.com Estimation for Validation Engineer (Cleaning Validation) in Swiftwater, PA
$96,142 to $120,665
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