4 дня назад
Manufacturing Senior Associate 12 Hour PM Shift (Biotech Manufacturing)
86 048 - 116 417$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manufacturing Senior Associate 12 Hour PM Shift (Biotech Manufacturing) (cGMP packaging and device assembly): Leading and supporting pharmaceutical manufacturing operations for device assembly and packaging lines with an accent on equipment operation, troubleshooting, compliance, and production continuity. Focus on resolving equipment and process issues, supporting qualification and validation, maintaining controlled documentation, and driving lean manufacturing improvements.
Location: New Albany, Ohio, United States; onsite manufacturing role on a 12-hour PM shift
Salary: USD 86,048.05–116,417.95 per year
Company
is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Lead device assembly and packaging line operations while maintaining production in full cGMP compliance.
- Support equipment setup, operation, troubleshooting, fault clearing, and stoppage resolution to maintain machine uptime.
- Supervise, develop, and train manufacturing technicians on processes and equipment.
- Provide technical support for equipment, automation, and process issues, escalating safety, quality, supply, and functionality risks.
- Collaborate with Quality, Engineering, Manufacturing Support, Process Development, Regulatory Compliance, and plant leadership to resolve manufacturing events.
- Support deviation triage, CAPA, controlled documentation, commissioning, qualification, validation, and continuous improvement initiatives.
Requirements
- High school diploma/GED plus 4 years of biotech or pharmaceutical manufacturing, process development, or quality experience; or an associate degree plus 2 years; or a bachelor's degree plus 6 months; or a master's degree.
- Technical understanding of pharmaceutical or biotech packaging equipment and processes.
- Experience with current Good Manufacturing Practices (cGMP) and manufacturing operations, technical support, process development, or scheduling.
- Ability to analyze technical data, manage competing priorities, adapt to change, and work in cross-functional teams.
- Experience with commissioning and qualification, new product introduction, cleaning validation, and process performance qualification is preferred.
- Experience with manufacturing electronic systems such as MES, LIMS, Maximo, CCMS, or SAP is preferred.
Nice to have
- Degree in Chemical Engineering, Industrial Engineering, or Life Sciences.
- Background in lean manufacturing methodologies and operational excellence.
- Experience in GMP technology support, GMP operations, or process development.
Culture & Benefits
- Collaborative, innovative, science-based work environment focused on serving patients.
- Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
- 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.
- Sponsorship for this role is not guaranteed.
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