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5 дней назад

Sr. Associate - Manufacturing - Engineering Support (Biotech)

86 048 - 116 417$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Sr. Associate - Manufacturing - Engineering Support (Biotech): Supporting pharmaceutical manufacturing and quality systems with an accent on process validation, technology transfer, process monitoring, and non-conformance management. Focus on implementing process improvements, investigating deviations and CAPA, managing change controls, and supporting manufacturing process and equipment modifications.

Location: New Albany, Ohio, United States

Salary: $86,048.05–$116,417.95 per year

Company

hirify.global is a biotechnology company that researches, manufactures, and delivers medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

  • Support manufacturing and quality systems, including continuous improvement, technology transfer, new product introductions, process validation, training, and non-conformance management.
  • Own, revise, and approve manufacturing procedures and assess process performance through floor observations and data review.
  • Identify, plan, and implement process improvements, including cost and cycle-time reduction initiatives.
  • Monitor process parameters and control limits, collect data, assess deviations, and support quarterly process-monitoring reports.
  • Support technology transfers, equipment and process modifications, change controls, and project implementation.
  • Assist with investigations, corrective actions, CAPA closure, validation protocols and reports, root-cause analysis, and regulatory inspections.

Requirements

  • High school diploma or GED plus 4 years of relevant experience; or an associate degree plus 2 years; or a bachelor's degree plus 6 months; or a master's degree.
  • Relevant experience must be in engineering, manufacturing, packaging, or quality within pharmaceutical, medical device, or biotechnology companies.
  • Technical understanding of bioprocessing and manufacturing operations, with experience in GMP production operations.
  • Experience with process improvement, Lean principles, Kaizen, Six Sigma, operational excellence, and problem-solving techniques.
  • Knowledge of change control, regulatory interactions, project management, data analysis, and control charting.
  • Strong organizational, technical writing, presentation, communication, and cross-functional collaboration skills.

Culture & Benefits

  • Collaborative, innovative, and science-based working environment.
  • Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
  • Retirement and savings plan with company contributions, stock-based long-term incentives, and a discretionary annual bonus program.
  • Paid time-off plans, work-life balance support, and career development opportunities.
  • Flexible work models where applicable to the role.

Hiring process

  • Sponsorship for this role is not guaranteed.
  • Reasonable accommodations are available for candidates with disabilities during application and interview processes.

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