Manufacturing Lead Downstream - Days

FUJIFILM Biotechnologies; North Carolina; Vor Ort; USD 75.000 - 95.000; Vollzeit

Zusammenfassung

Merck & Co. is looking for a Manufacturing Lead to oversee and execute manufacturing processing steps in a 24/7 facility in North Carolina. The candidate will ensure compliance with safety protocols and CGMP standards, while training junior associates and troubleshooting operational issues.

The ideal candidate will have substantial experience in CGMP environments, with leadership capabilities and a commitment to continuous improvement.

Qualifikationen

• 8+ years of experience in a CGMP manufacturing environment.
• Experience with multiple unit operations preferred.
• Ability to conduct work in varying environmental conditions.

Aufgaben

• Leads and executes manufacturing processing steps.
• Trains and mentors junior associates.
• Contributes to manufacturing continuous improvement efforts.

Kenntnisse

Experience in CGMP manufacturing

Leadership and mentoring skills

Safety protocol adherence

Problem-solving skills

Ausbildung

High School Diploma/GED

Associate's degree in life science

Bachelor's degree in life science

Jobbeschreibung

Position Overview

The Manufacturing Lead executes and leads manufacturing processing steps, associated activities, and assists the supervisor/manager, as needed. The Lead adheres to and helps ensures all activities performed within the designed shift comply with Current Good Manufacturing Practice (CGMP) and other safety or quality standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

Job Description

Responsibilities

• Adheres to strict safety protocols and contributes to building a culture of safety within the manufacturing environment
• Leads, executes, and documents manufacturing processing steps or support activities, process monitoring and control within a functional area, ensuring compliance with standard operating procedures (SOPs) and Current Good Manufacturing Practice (CGMP) regulations
• Oversees, leads, or performs in-process sampling and testing (e.g., pH, conductivity, visual inspection)
• Executes validation protocols according to CGMP SOPs and provides approval as a back-up for the supervisor/manager, as needed
• Trains and mentors junior associates to enhance team capabilities
• Supports scheduling daily activities on the manufacturing floor and serves as a back-up for the supervisor, as needed
• Leads troubleshooting for operational issues
• Assists the supervisor with shift huddles and tier escalations, investigations, and continuous improvement projects
• Serves as the functional lead for manufacturing execution responsibilities
• Contributes to manufacturing continuous improvement efforts
• Serves as the subject matter expert (SME) in at least two core responsibilities for manufacturing assigned area
• Maintains training to perform all required activities
• Performs other duties, assigned

Requirements

• High School Diploma/GED with 8+ years of experience in a CGMP manufacturing environment; or
• Associate's degree in life science with 6+ years of experience in a CGMP manufacturing environment; or
• Bachelor's degree in life science with 4+ years of experience in a CGMP environment; or
• Equivalent Military training or experience

Preferred Requirements

• Experience with multiple unit operation (e.g., Chromatography, UFDF, etc.) and fully qualified in at least one functional area

Physical Demands

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Will work in environment which may necessitate respiratory protection.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 240 minutes
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 33 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions

Environmental Conditions

• Will work in warm/cold environments (0-100F).

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).