Lead Technician, Manufacturing

Adare Pharma Solutions Recruiting Team•Vandalia, OH

8d•Onsite

About The Position

The Lead Technician, Manufacturing is a hands-on production resource and senior technical resource within the manufacturing organization. The role provides day-to-day technical leadership, coordinates onboarding across assigned production areas, and supports successful batch execution. It partners closely with Production Supervisors and cross-functional teams to help ensure safe, compliant, and efficient manufacturing operations. During technology transfer and new product introduction activities, the Lead is among the first manufacturing personnel trained on new commercial products, processes, and equipment, partnering with Research & Development, Engineering, Quality, Validation, and other teams to develop process expertise and support implementation in Manufacturing. The position trains and qualifies new employees, supports process execution, troubleshoots operational challenges, reinforces quality and data integrity expectations, and models manufacturing excellence. It has no direct supervisory responsibility, but is expected to influence others through technical expertise, coaching, and leadership by example. The role is located in Vandalia, Ohio, and involves working in pharmaceutical manufacturing areas and production suites.

Requirements

High school diploma or GED.
At least 3 years of experience in a 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), GMP decision-making, and quality focus.
Strong troubleshooting and problem-solving skills.
Ability to interpret and follow Batch Manufacturing Records, SOPs, and work instructions.
Strong sense of ownership and accountability.
Strong verbal and written communication skills.
Effective interpersonal skills and 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.
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.
Ability to stand, walk, bend, reach, push, pull, and twist, and perform routine manufacturing-floor activities for extended periods.
Ability to wear required PPE, including safety glasses, hearing protection, gloves, respirators, and protective garments.
Ability to occasionally lift, move, or transport materials, tools, and equipment consistent with job requirements.
Ability to occasionally climb stairs, ladders, and access platforms to interact with manufacturing equipment.
Ability to read and interpret production records, equipment displays, gauges, scales, and other manufacturing instruments.
Ability to work around manufacturing equipment, moving machinery, powders, cleaning agents, and process-related materials.
Sufficient visual acuity and manual dexterity to perform manufacturing, inspection, and documentation activities.
Ability to meet applicable medical, respiratory, and safety clearance requirements associated with assigned duties.

Responsibilities

Lead by example in dispensing, granulation, compression, encapsulation, and other manufacturing operations, ensuring safe, compliant, and efficient batch execution.
Support Supervisors in maintaining operational readiness and executing the production schedule.
Troubleshoot process, 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 process-improvement opportunities and support operational excellence and departmental or cross-functional initiatives.
Serve as the primary technical trainer for newly hired manufacturing employees.
Collaborate with the Training department to develop onboarding and qualification requirements.
Mentor and coach manufacturing personnel to support their ongoing development.
Evaluate trainee performance and proficiency against established qualification requirements.
Partner with RDF, MS&T, and other cross-functional teams during technology transfers and new product or technology introductions.
Develop competency in new manufacturing processes and equipment to support commercialization.
Assist in developing, coordinating, and delivering manufacturing training related to technology transfers 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.
Demonstrate professionalism, reliability, and accountability while contributing to a productive, team-oriented workplace.
Prioritize safety by following company policies and safe work practices, wearing required PPE, and promptly reporting unsafe conditions.
Foster effective working relationships through clear communication, mutual respect, and collaboration with coworkers and cross-functional teams.
Participate in Lean, 5S, and continuous-improvement initiatives, seeking ways to improve quality, efficiency, and workplace organization.
Monitor and promote adherence to ALCOA+ and data-integrity principles.
Perform other duties as assigned.