Lead Manufacturing Technician

3390 Baxalta U.S.•Round Lake, IL

26d•Onsite

About The Position

The Lead Manufacturing Technician drives operational excellence in manufacturing and scheduling to meet site demands, leading floor operations with a strong focus on safety, aseptic practices, and compliance with cGMP standards. The role optimizes materials, equipment, and personnel to support efficient day-to-day execution and provides technical leadership by collaborating with cross-functional support teams to ensure process changes and improvements are implemented accurately on the manufacturing floor. The technician also identifies and integrates appropriate best practices to enhance manufacturing performance and continuous improvement. This position works a 2-2-3 rotating shift, with scheduled hours from 5:00 AM to 5:30 PM. It is considered essential personnel and may require reporting for a normal shift during inclement weather when management deems necessary. The work involves controlled manufacturing environments, special gowning and protective clothing, and potential exposure to chemicals, cold or wet conditions, and loud areas. Physical activities may include lifting, pulling, or pushing with up to 25–50 lbs. of force, standing for up to six hours in a production suite, climbing ladders and platforms, and stooping or bending to inspect or troubleshoot equipment.

Requirements

High school diploma with at least 6 years of related industry experience, or an associate degree in life sciences, engineering, or a related field with at least 5 years of GMP manufacturing experience.
Demonstrated proficiency in aseptic technique and cleanroom manufacturing practices.
Working knowledge of manufacturing systems, production equipment, and routine operational processes.
Strong understanding of cGMP requirements and applicable regulatory expectations, including FDA and EMA requirements.
Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
Ability to lift, pull, or push equipment requiring up to 25–50 lbs. of force.
Ability to stand for up to 6 hours in a production suite.
Ability to climb ladders and work platforms, and to stoop or bend to check or troubleshoot equipment operations.
Ability to work around chemicals such as alcohols, acids, and bases.
Ability to work a 2-2-3 rotating shift with hours from 5:00 AM to 5:30 PM; may work multiple shifts, including weekends, or supplemental hours as necessary.
Ability to comply with manufacturing environment requirements, including special gowning and restrictions on makeup, jewelry, contact lenses, nail polish, and artificial fingernails.
May be required to report to work during inclement weather if management deems necessary.

Nice To Haves

Prior experience in a manufacturing lead, team support, or coordination role.
Biotech certificate or other relevant technical certification.
Experience with systems such as SAP, LIMS, and TrackWise.

Responsibilities

Serve as the primary point of contact for troubleshooting, issue resolution, and escalation.
Coordinate daily scheduling, staffing, and real-time staff assignments to support operational needs.
Oversee and execute routine and critical manufacturing operations, including commissioning and changeover/validation activities.
Ensure documentation is completed, reviewed, and maintained in accordance with good documentation practices and cGMP requirements.
Manage floor inventory, monitor material usage, and coordinate material deliveries and schedule changes.
Promote safe, compliant operations by reinforcing safety practices, identifying risks, and escalating concerns appropriately.
Support continuous improvement by applying visual management practices and recommending process, safety, and ergonomic enhancements.
Provide team leadership through training, coaching, performance feedback, and assessment of staff skills and development needs.
Support quality systems by initiating and contributing to deviations, investigations, CAPAs, and related GMP documentation.
Collaborate with cross-functional teams, including QA, engineering, facilities, and operations, to resolve issues and support tech transfer activities.