Validation Specialist - Swiftwater, United States - Mindlance
Description
Job Title: Validation Specialist III (Engineering)
Location: Swiftwater, PA
Duration: 12 months with possibility of extension
Notes:
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. 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: 1. cleaning validation experience 2. strong communication skills 3. ability to manage, execute and troubleshoot on their own 4. Strong Microsoft Suite skills
Job Description:
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.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.