This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Supervise daily activities in a production area to meet manufacturing goals and deadlines while ensuring compliance with GMPs, SOPs, environmental health and safety guidelines, and other regulations. Oversee operations, ensure efficiency, and lead teams in optimization of safety, quality, service, and cost. Manage direct reports, implement lean manufacturing principles, and handle technical reviews, investigations, and process improvement initiatives. Collaborate with multi-disciplinary teams and represent the company during FDA inspections.
Job Responsibility:
Communicates guidance, support, direction and leadership through effective interactions with all personnel during daily operations
supervises the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities
identifies, prioritizes and provides resources as appropriate
interviews, hires, coaches, motivates, develops, recognizes and manages performance of direct reports
provides regular feedback to all direct reports
assists in setting performance objectives and development plans and supervises progress
reviews, approves, and leads documentation for batch and system records
assists in meeting product release time goals
identifies, initiates and facilitates continuous improvements, lean manufacturing activities, and initiatives
ensures resources and raw materials are applied in the most efficient and productive manner possible
develops training content and facilitates and verifies appropriate training for employees in the area
ensures compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required
submits and/or maintains and distributes reports related to attendance, labor, efficiency, safety, scrap and others as needed
performs and leads technical reviews, investigations and process improvement projects
provides manufacturing input into integration and validation of new equipment and processes
resolves technical, material and cGMP problems that may impact project deadlines
provides guidance and troubleshooting assistance as needed during a deviation in the process
may represent the company during FDA inspections or provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs
may monitor capital expenditures and assist in developing budgets.
Requirements:
Bachelor's degree preferred
minimum Associates degree with technical subject area required
and/or 3 years manufacturing experience and 2 years of supervisory experience
consistent track record of interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment
in-depth process knowledge of related manufacturing equipment and processes
ability to lead multiple priorities in a manufacturing plant setting
ability to analyze and interpret scientific and statistical data
strong professional writing skills and ability to prepare technical reports
ability to clearly articulate information during regulatory/client inspections
ability to understand GMPs and other applicable regulatory guidelines
strong assessment and troubleshooting skills
ability to respond to detailed inquiries and present information to groups and senior leaders
ability to supervise multiple groups/shifts, if applicable
computer proficiency in Microsoft Office and ability to use enterprise software
ability to collect and analyze data and information to resolve paths for process improvement and potential root cause
demonstrated critical thinking and problem-solving skills
solid understanding of manufacturing business sense
applicants must be authorized to work for any employer in the U.S.
Nice to have:
Bachelor's degree
knowledge of GMPs and regulatory guidelines
proficiency in enterprise software
knowledge of lean manufacturing principles such as 5S, visual management, and kaizens
What we offer:
Medical, Dental, and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Paid Parental Leave
Tuition Reimbursement
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP) with discount
401(k) Retirement Savings Plan (RSP) with employee contributions and company matching
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