Manufacturing Leader

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. in Ohio is seeking an Operations Group Leader to oversee daily manufacturing activities, ensuring product quality, safety, and schedule execution.

The role provides leadership to hourly staff and collaborates with engineering and quality teams to meet customer service requirements. The ideal candidate has at least five years in manufacturing (GMP or non-GMP) and strong communication and problem-solving skills, with a track record in training and continuous

Qualifications

• High School diploma or equivalent is required.
• Five years in a non GMP environment or two years in a GMP environment.
• Aseptic technique training and clean room experience preferred.
• Strong communication and documentation skills in a regulated setting.

Responsibilities

• Ensure regular onsite attendance and punctuality.
• Adhere to safety, environmental and quality SOPs and policies.
• Lead hourly production staff with coaching and guidance.
• Investigate and report production deviations and issues.
• Provide phase-in training for new and existing staff.
• Coordinate functions across Filling, Inspection, and Packaging.
• Maintain training records and monitor line performance.
• Support management projects and material coordination.

Skills

Interpersonal communication

Leadership

Document writing

Cross-functional coordination

Problem solving

Computer literacy

Education

High School diploma or equivalent

Tools

Training management systems

Label verification vision systems

Line management data capture systems

Job description

Description: We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Operations Group Leader. In this role, you will be responsible for providing support to Manufacturing under the general direction of Operations Management. This role provides the necessary leadership to achieve product quality, cost control, cGMP compliance, safety, and the execution of the production schedule to support the customer service requirements.

Key Responsibilities

• Regular and predictable onsite attendance and punctuality.
• Adheres to all environmental, health and safety SOPs, policies and procedures, including any department specific requirements.
• Coordinates and oversees daily activities of hourly production staff providing leadership assistance and necessary coaching.
• Initiates and completes investigative reports for production related process deviations.
• Provides phase-in training for new and existing employees.
• Provides conflict resolution and handles general problems/requests when necessary.
• Coordinates all functions and lead efforts related to Filling, Inspection and/or Packaging based on assigned department.
• Evaluates/enforces current practices within areas of responsibility.
• Coordinates orders for production related materials.
• Provides problem investigation and resolution. Supports management and engineering projects as assigned.
• Maintains training records for individual departments and production areas.
• May create and run reports tracking line performance

Qualifications

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

Education

• Minimum: High School diploma or equivalent is required.

Experience

• Minimum: Five [5] years’ experience in a non GMP environment; or two [2] years’ experience within a GMP manufacturing environment.
• Preferred: Prior aseptic technique training and working in a clean room environment.

Language Skills

• Have strong interpersonal skills and be an excellent communicator who can successfully interact and coordinate activities across departmental boundaries and at varying levels within the organization.
• Excellent writing skills are essential. Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs

Mathematical Skills

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Able to perform mathematical calculations associated with production documentation analysis and problem solving.

Technical Skills

• Technically oriented with ability to analyze problems and suggest solutions.
• Ability and working knowledge of how to use a computer.
• Knowledgeable in site training management systems is preferred.
• Knowledgeable in site label verification vision systems is preferred.
• Knowledgeable in line management data capture systems is preferred.

Leadership Skills

• Has demonstrated leadership skills or has shown potential leadership abilities in his/her work.

Physical Demands

• The duties of this job involve walking, lifting (up to 40 lbs.), bending, and sitting. Majority of the time is spent in the performance of manual inspection, paperwork and coordination of line activities.
• Good visual acuity with or without eyeglasses/contacts (eye exam required).
• On the production floor you will be totally gowned with mask, hood, coverall, and gloves. At times, the environment can be confining. The noise level is moderate to loud. Use of hearing protection may be required. The use of sanitizing agents to clean the filling room may be moderately disagreeable. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Employer

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.