SOKOL GxP Services

Process Engineering Scientist

SOKOL GxP Services

contract

Posted on:

Location Type: Hybrid

Location: New Brunswick • New Jersey • 🇺🇸 United States

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Salary

💰 $52 - $66 per hour

Job Level

Mid-LevelSenior

About the role

  • Responsible for supporting MS&T Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.
  • Design and run experiments.
  • Perform risk assessments, including but not limited to Material and Process Risk assessment, Nitrosamines Risk Assessment, Elemental Impurities Risk assessment etc.
  • Complete, analyze and present data analysis.
  • Support tech transfer activities in the form of generating test plans, change controls, executing and compiling results into reports.
  • Supports validation efforts in the development of validation strategies and testing plans.
  • Provide input into process related investigations and complete MST investigations as required.
  • Advise on root-cause analysis of undesired trends or deviations related to process equipment.
  • Support monitoring of studies at manufacturing areas, Contract Manufacturers, as needed.
  • Support the Change Control process.
  • Position does handle hazardous material.

Requirements

  • Bachelor's Degree in a Science Related field;
  • 6+ years of DP technical experience, support during experimental phase and process validation and the Pharma space for oral solids. Experience writing OSD strategies, study plans, study reports, validation protocols and reports.
  • 4+ years of expertise in data evaluation, 4+ years of expertise managing Risk Assessments.
  • 5+ years of expertise working process related Investigations and change controls.
  • Experience working in or supporting pharmaceutical operations require - minimum of 4 years.
  • Comfortable wearing proper PPE and working in a Laboratory - time in Laboratory will fluctuate.
  • Strong communication skills, working with a team, and accountable for their work.
Benefits
  • Competitive hourly rate: **$51.81 – $65.81/hr (W-2 only, no C2C)**
  • Hybrid schedule (50% onsite)
  • Working Hours: Monday - Friday, business hours
  • 12-month contract with possible extension
  • Health benefits, holiday pay, and 401(k) program
  • Paid time off (UTO) and professional development support
  • Employee referral bonus program
  • Opportunity to contribute to high-impact projects with a leading biopharma company

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
data analysisrisk assessmentprocess validationexperimental designtechnical writingroot-cause analysisvalidation strategiestest planschange controlmonitoring studies
Soft skills
communicationteamworkaccountability
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