Validation Specialist

Job Title: Validation SpecialistLocation: Swiftwater, PADuration: 12 months with possibility of extension

Job Description: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.

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 experiencestrong communication skillsability to manage, execute and troubleshoot on their ownStrong Microsoft Suite skills

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 experienceo Acceptance criteria determinationo Sampling plans and sample size determinationo Rinse and Swab sampling experienceo Bracketing and worse case ratingo QC testing requirementso Dirty hold times and clean hold times

Basic Qualifications:Experience utilizing Microsoft Word, Excel, and OutlookExperience writing and revising documents (e.g. testing methods, protocols, reports)Experience performing testing in a GMP settingMS Project experience

Skills:Proficiency in utilizing documentation system to author protocols and reportsExperience participating in teams and collaborative work environments.Good communication skills (verbal and written), math skills, general computer skillsTeam environment a mustE Doc/GEODE+ experience with a working knowledge of templates, workflows and approval processStrong 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

EEO:Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of

Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.by Jobble #J-18808-Ljbffr