Validation Specialist III - BH7581

Full Time
Swiftwater, PA 18370
Posted
Job description

Job Title: Validation Specialist III

Location: Swiftwater, PA. Onsite, 4 days a week most likely.

Duration: 8+ Months

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

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Types: Contract, Temporary

Pay: Up to $78.00 per hour

Benefits:

  • Dental insurance
  • Health insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Education:

  • Bachelor's (Required)

Experience:

  • Cleaning validation (CV): 1 year (Preferred)
  • pharma: 1 year (Required)
  • bio pharma: 1 year (Required)
  • root cause analysis with cGMP: 1 year (Required)

Work Location: In person

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