6 дней назад
Sr. Associate - Manufacturing - Engineering Support (Biotechnology)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Sr. Associate - Manufacturing - Engineering Support (Biotechnology): Supporting pharmaceutical manufacturing and quality systems through process improvement, technology transfer, validation, change control, and non-conformance management with an accent on GMP operations, process monitoring, and engineering support. Focus on assessing process performance, implementing manufacturing improvements, analyzing validation and deviation data, and coordinating CAPA and equipment modification projects.
Location: New Albany, Ohio, United States; onsite manufacturing support role.
Company
is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Own, revise, and approve manufacturing procedures and assess process performance through floor observation and operational data review.
- Identify and implement process improvements focused on cost reduction, cycle-time reduction, and operational effectiveness.
- Support process monitoring, control limits, quarterly reporting, deviation assessment, and troubleshooting.
- Participate in technology transfer, new product introductions, process validation, and equipment or process modification projects.
- Support non-conformance investigations, corrective actions, CAPA closure, root-cause analysis, and incident trend evaluation.
- Provide manufacturing change-control assessments, training support, regulatory inspection participation, and validation documentation.
Requirements
- High school/GED plus 4 years, associate degree plus 2 years, bachelor's degree plus 6 months, or master's degree in a relevant field or equivalent experience.
- Experience in engineering, manufacturing, packaging, or quality within pharmaceutical, medical device, or biotechnology companies.
- Detailed understanding of bioprocessing and manufacturing operations, including GMP production operations.
- Experience with Lean principles, Kaizen, Six Sigma, operational excellence, problem-solving, and cross-functional collaboration.
- Knowledge of change control, regulatory interactions, project management, data analysis, and control charting.
- Strong organizational, technical writing, presentation, and verbal communication skills.
Culture & Benefits
- Health, dental, vision, life, and disability insurance.
- Retirement and savings plan with company contributions and flexible spending accounts.
- Annual bonus program and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
- Flexible work models where applicable to the role.
- Collaborative, science-based, and inclusive work environment.
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