Job Description:

The Manufacturing Support Lead supports daily manufacturing operations and serves as the frontline technical and operational leader within the Manufacturing Support department. This role provides day-to-day guidance, training, coordination, and technical expertise to manufacturing associates while supporting equipment qualifications, process improvements, documentation ownership, and compliant pharmaceutical manufacturing operations. The Manufacturing Lead promotes safe, efficient, and compliant production while fostering collaboration, continuous improvement, and adherence to the Civica mission of serving patients.

Essential Duties and Responsibilities:

• Provide daily direction, coordination, and support to Manufacturing Associates during routine operations.

• Act as a subject matter expert for manufacturing support processes including autoclaves, parts washers, clean-in-place (CIP), and material transfer isolators (MTIs).

• Support equipment qualification, commissioning, validation, and start-up activities.

• Serve as the primary point of contact for operational issues and escalate concerns to supervision when necessary.

• Assist with maintaining inspection readiness and support regulatory inspections and audits.

• Ensure personnel are trained and qualified prior to performing assigned activities.

• Support development, revision, and implementation of SOPs, batch records, and governing documents.

• Promote compliance with FDA, cGMP, ISO, safety, and company requirements.

• Identify and implement process improvements using Lean Manufacturing principles.

• Assist with investigations, root cause analysis, deviations, CAPAs, and change controls.

• Mentor and train associates on technical processes, documentation practices, and operational excellence.

• Coordinate activities across shifts and departments to ensure operational continuity and effective communication.

• Maintain accurate production and compliance documentation.

• Provide operational feedback to leadership regarding staffing, training, and process improvement opportunities.

• Maintain flexibility to support production schedules and business needs.

• Ability to work on-site is required.

Basic Qualifications and Capabilities:

• High school diploma or equivalent with 3+ years of Operations or Manufacturing Support experience in Pharmaceuticals (cGMP, FDA-regulated, ISO, or similar manufacturing environment).

• Experience with autoclaves, parts washers, and manufacturing support equipment.

• Previous experience serving as a team lead, trainer, or informal leader in a GMP manufacturing environment preferred.

• Knowledge of process improvement, change management, and manufacturing investigations.

• Lean Manufacturing and/or Six Sigma experience preferred.

• Strong documentation, communication, and interpersonal skills.

• Self-directed with strong problem-solving and analytical abilities.

• Ability to collaborate effectively across departments and shifts.

Physical Demands and Work Environment:

The physical demands described here are representative of those required to perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee is frequently required to use their hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate. The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.