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Production Operator – Pharmaceutical Micronization

On-site, Bethlehem, Pennsylvania, United States

The Production Operator is responsible for overseeing world class standards in pharmaceutical milling and micronization services, safety, quality and environmental standards in line with cGMP, customer requirements and internal operating procedures.

Key Responsibilities:

Manufacturing Operations

• Operate, monitor, and clean micronization and related manufacturing equipment in accordance with approved procedures and work instructions.
• Execute manufacturing activities according to production schedules, batch records, and operational priorities.
• Perform equipment setup, changeovers, cleaning, and line clearance activities.
• Conduct routine equipment inspections and identify operational issues.
• Maintain production areas in a clean, organized, and inspection-ready condition.
• Follow all cGMP, safety, environmental, and quality requirements.

Documentation & Compliance

• Complete production documentation accurately, legibly, and in a timely manner in accordance with Good Documentation Practices (GDP).
• Review manufacturing documentation according to established procedures and the four-eye review principle where applicable.
• Identify, document, and report deviations, non-conformances, incidents, and unusual operating conditions.
• Participate in audits, inspections, investigations, and corrective action activities as required.
• Maintain compliance with all applicable regulatory and company requirements.

Warehouse Support

• Support material receipt, storage, staging, transfer, and shipment activities as required.
• Assist with inventory counts, material reconciliation, and stock management activities.
• Ensure proper identification, handling, and status labeling of materials in accordance with GMP requirements.
• Transfer materials safely between warehouse, production, and laboratory areas.

Cross-Functional Collaboration

• Work effectively with Production, Warehouse, Quality Control, Quality Assurance, Engineering, and Technical Services personnel.
• Escalate production delays, equipment malfunctions, quality concerns, and safety risks through established reporting channels.
• Participate in continuous improvement initiatives and operational projects.
• Support customer projects and business priorities as assigned.

Other Duties

• Perform other duties and responsibilities as assigned to support business operations.
• Demonstrate flexibility in supporting production, warehouse, laboratory, and other operational functions as business needs require.
• Respond to and execute ad hoc assignments, special projects, and operational requests from management in a timely and professional manner.

Qualifications & Competencies:

Education

• High School Diploma, GED, or equivalent required.
• Technical vocational training, apprenticeship, or relevant manufacturing certification preferred.
• Forklift license or willingness to obtain one.

Experience

• Previous experience in pharmaceutical, biotechnology, chemical, food, or other regulated manufacturing environments preferred.
• Experience operating manufacturing or processing equipment is advantageous.
• Experience working within a cGMP-regulated environment is preferred but not required.
• Ability to follow written procedures, batch records, and work instructions accurately.
• Basic understanding of cGMP requirements and documentation practices.
• Strong attention to detail and commitment to product quality.
• Good communication and teamwork skills.
• Basic computer skills and familiarity with electronic documentation systems.
• Ability to prioritize work and adapt to changing production requirements.
• Mechanical aptitude and troubleshooting skills are beneficial.

If this role sounds interesting and is relevant to your experience, then please apply directly above!

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.