10 дней назад
Operations Supervisor (Biotech Manufacturing)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Operations Supervisor (Biotech Manufacturing) (GMP/pharmaceutical manufacturing): Supervising GMP manufacturing and packaging operations, production teams, equipment qualification, cleaning activities, and site support with an accent on oral solid dosage processes, compliance, documentation, and safety. Focus on coordinating equipment startup, developing SOPs and work instructions, managing deviations and CAPA actions, and leading continuous improvement in a pharmaceutical manufacturing environment.
Location: Middletown, Delaware, United States; on-site
Company
operates in biotech manufacturing and pharmaceutical site operations.
What you will do
- Support the site construction and startup project by coordinating operations activities, vendor visits, equipment installation, qualification, testing, and startup.
- Supervise operators and technicians, assign workstations, coordinate team activities, provide training, and maintain team cohesion.
- Lead GMP manufacturing and packaging operations while meeting production schedules and maintaining hygiene, environmental, health, and safety standards.
- Manage GMP cleaning services and schedules, participate in equipment qualification and validation, and troubleshoot production issues.
- Review batch packaging records, maintain operational documentation, open deviations, and follow up on CAPA actions in the quality system.
- Serve as the area contact during audits, support risk assessments, report incidents and near misses, and drive continuous improvement.
Requirements
- At least a bachelor's or associate degree and more than 6 years of manufacturing site operations experience.
- Strong knowledge of GMP environments, pharmaceutical manufacturing, OSD processes, blending, encapsulation, powder compression, and dry-formulation packaging.
- Proven experience leading and managing teams, training employees, and communicating with internal and external stakeholders.
- Ability to develop and implement SOPs, operating procedures, work instructions, and technical documentation from the ground up.
- Knowledge of manufacturing and R&D operations, local codes and regulations, ERP systems, and basic Microsoft Office tools.
- English proficiency is required.
Culture & Benefits
- Fast-paced, startup-like construction and engineering environment with changing priorities.
- Requires adaptability, initiative, proactive problem-solving, and the ability to take on multiple responsibilities.
- Collaborative, team-oriented work with internal teams, vendors, contractors, government departments, and other stakeholders.
- Focus on safe behavior, regulatory compliance, operational quality, and continuous improvement.
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