5 дней назад
Sr. Associate - Manufacturing - Engineering Support (Biotech)
86 048 - 116 417$
Мэтч & Сопровод
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Описание вакансии
Текст:
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
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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