Lead Technician, Manufacturing

Adare Pharma Solutions Recruiting Team•Vandalia, OH

1d•Onsite

About The Position

The Manufacturing Technician Lead is a hand-on production resource that serves as the senior technical resource within the manufacturing organization, providing day-to-day technical leadership, onboarding coordination across assigned production areas and operational support for successful batch execution. This position partners closely with Production Supervisors and other cross-functional teams to ensure safe, compliant, and efficient manufacturing operations. During technology transfer and new product introduction activities, the Manufacturing Lead will be among the first manufacturing personnel trained on new commercial products, processes, and equipment. The role partners closely with Research & Development (RDF), Engineering, Quality, Validation, and other cross-functional teams to develop process expertise and support successful implementation within Manufacturing. The Manufacturing Technician Lead is responsible for training and qualifying new employees, supporting process execution, troubleshooting operational challenges, reinforcing quality and data integrity expectations, and serving as a role model for manufacturing excellence. While this position does not have direct supervisory responsibility, it is expected to influence others through technical expertise, coaching, and leadership by example.

Requirements

High School Diploma or GED required
3+ years of experience in pharmaceutical or allied manufacturing environment.
Experience training, mentoring and qualifying manufacturing personnel.
Demonstrated knowledge of cGMP regulations and pharmaceutical manufacturing operations.
Strong understanding of data integrity (ALCOA) and GMP decision making and quality focus.
Strong troubleshooting and problem-solving skills.
Ability to interpret and follow Batch Manufacturing Records, SOPs, work instructions.
Strong sense of ownership and accountability.
Strong verbal and written communication skills.
Effective interpersonal skills with the ability to work across multiple functional areas.
Proficiency with computer systems, electronic documentation, and manufacturing-related software applications.
Ability to organize and prioritize multiple tasks while maintaining attention to detail.
Demonstrated ability to work independently and as part of a team.
Ability to develop working knowledge of new manufacturing technologies, equipment, and processes.
Adaptability in a fast-paced commercial manufacturing environment.
Experience supporting manufacturing investigations and continuous improvement initiatives.
Knowledge of batch record review requirements and manufacturing compliance systems.
Ability to interpret technical documents

Responsibilities

Lead by example in the execution of dispensing, granulation, compression, encapsulation, and other manufacturing operations as required while ensuring safe, compliant, and efficient batch execution.
Support Supervisors in maintaining operational readiness and execution of the production schedule.
Assist with troubleshooting processes, equipment, and documentation issues to minimize production interruptions.
Serve as a technical resource for operators and supervisors during routine and non-routine manufacturing activities.
Identify opportunities for process improvement and support implementation of operational excellence initiatives and departmental/cross-functional initiatives.
Serve as the primary technical trainer for new hired manufacturing employees.
Collaborate with Training department on development of on-boarding and qualification requirements.
Provide ongoing mentoring/coaching to manufacturing personnel to support continuous development.
Evaluate trainee performance and proficiency against established qualification requirements.
Partner with RDF, MS&T and other cross-functional teams during technology transfer activities as well as new product and new technology introductions.
Develop competency on new manufacturing processes and equipment to support commercialization.
Assist in the development and subsequent coordination and delivery of manufacturing training related to technology transfer and new products, processes, and equipment.
Support manufacturing investigations, deviation assessments, corrective actions, and continuous improvement initiatives.
Support change control, validation, engineering, and quality-related activities as needed.
Exhibit professionalism, reliability, and accountability while contributing to a productive and team-oriented workplace.
Prioritize safety in all daily activities by adhering to company policies, following safe work practices, wearing required PPE, and reporting unsafe conditions without delay.
Foster strong working relationships through clear communication, mutual respect, and effective collaboration with coworkers and cross-functional teams.
Actively participate in Lean, 5S, and continuous improvement initiatives. Seek opportunities to improve quality, efficiency, and workplace organization while helping sustain operational excellence.
Monitor and promote adherence to ALCOA+ and data integrity principles.
Perform other duties as assigned.