Manufacturing Supervisor
hace 5 días
Hauppauge
Manufacturing Supervisor – DPI (1st, 2nd, or 3rd Shift) Work Location: Hauppauge, NY Employment: Full-Time | On-Site Industry: Pharmaceutical Manufacturing A large regulated pharmaceutical manufacturing facility in Hauppauge, NY, is seeking a Manufacturing Supervisor (Dry Powder Inhalation – DPI) to lead operations on the production floor. This role will supervise teams, support production schedules, champion safety and quality standards, and ensure compliance with cGMP guidelines. Position Summary This role oversees the daily operations of DPI manufacturing and supports product development, commercial production, documentation, and safety compliance. The Supervisor will lead a team of operators and collaborate with cross-functional departments to achieve manufacturing schedules and maintain product quality. Key Responsibilities • Lead and supervise manufacturing activities for DPI products in a cleanroom/controlled environment, • Assign tasks, support daily troubleshooting, and ensure adherence to SOPs and cGMP, • Review batch manufacturing records and support investigations, deviations, and documentation, • Coordinate with QA, QC, R&D, Maintenance, Supply Chain, and other departments, • Support validation batches, bio-batch execution, and technical transfers, • Enforce safety procedures, equipment cleaning, and facility standards, • Train and evaluate employees based on performance expectations and policy guidelines, • Participate in audits, compliance reviews, and regulatory inspections, • Monitor productivity, equipment performance, and process improvements, • Maintain accurate technical documentation and compliant records, • Support extended working hours or weekends if required by production demand Required Qualifications ✔ Bachelor’s or Master’s degree in Pharmaceutical Sciences, Pharmaceutical Engineering, or related fields ✔ 1–3 years of hands-on experience in pharmaceutical or regulated manufacturing ✔ Strong understanding of cGMP, SOPs, compliance, documentation, quality & safety ✔ Ability to investigate deviations and support root cause analysis ✔ Proficiency in Microsoft Office; familiarity with SAP is a plus Preferred Background • Pharmaceutical / Biopharmaceutical Manufacturing, • Medical Device / Sterile Manufacturing, • Respiratory Technology Products (MDI, DPI preferred), • FDA/USP/GMP-Regulated Production Work Schedule • Primary Opening: 2nd Shift, • Additional shifts may be available (1st, 2nd, or 3rd) based on business needs Benefits Overview (Company Policy Applies) • Medical, Dental, Vision insurance, • 401(k) with company match, • HSA / FSA Programs, • PTO (Vacation / Sick / Flex Days / Holidays), • Disability, Parental Leave, Family Leave, • Employee Discounts & additional corporate benefits