Production Operations Group Lead - Night Shift
Takeda
2 months ago
On-site
Round Lake Beach, IL
$71,800 - $112,860 USD yearly
Operations
Production Operations Group Lead (Night Shift)
Responsibilities
- Supervise initial inspection, pasteurization, and incubator production area activities.
- Ensure manufacturing goals are achieved while maintaining compliance with cGMP, EHS, and applicable regulatory requirements.
- Monitor labor and capital spending; recommend improvements to manufacturing policies, procedures, and programs.
- Provide guidance, support, and leadership to employees.
- Supervise daily production, scheduling, staffing, material management, compliance, training, and audits.
- Review and approve batch and system records; support product release timing goals.
- Ensure staff complete training on time and follow cGMP and EHS requirements.
- Lead simple process improvement projects; provide manufacturing input for new equipment/process integration and validation.
- Resolve technical/material/cGMP issues affecting deadlines; provide troubleshooting during deviations.
- Represent the company during FDA inspections.
- Conduct daily gemba walks; apply lean principles with ongoing coaching.
- Perform basic auditing tasks under supervision and troubleshoot simple problems.
Qualifications
- High School Diploma or GED with 5+ years related experience; or bachelor’s degree in science/engineering (or related technical field) with 2+ years related experience.
Required/Preferred Skills
- Ability to work across departments and contribute to team leadership.
- Strong verbal/written communication, teamwork, documentation, and customer service; safe performance under pressure.
- Understanding of cGMP and relevant regulatory requirements (pharmaceutical/medical industry).
- Continuous improvement process concepts (with support).
- Proficient in MS Word and MS Excel.
- FDA-regulated environment experience preferred.
Shift/Work Requirements (Important Considerations)
- Night Shift (C/D): 5:00 p.m.–5:30 a.m.; 2-2-3 rotating schedule.
- Work in controlled/clean environments with PPE; remove makeup/jewelry/contact lenses/nail polish/artificial fingernails.
- Work in cold/wet conditions; may work weekends/holidays and supplemental hours.
- Work around chemicals (e.g., alcohols, acids, buffers, Celite) that may require respiratory protection.
- Physical requirements: carry/lift/push/pull up to 30 lbs. (with assistance equipment); stand/walk extended periods across 8–12 hour shifts.
- Indoor working conditions; work around moving equipment; may be required to work in confined areas; some clean room and cool/hot storage conditions.
Responsibilities
- Supervise initial inspection, pasteurization, and incubator production area activities.
- Ensure manufacturing goals are achieved while maintaining compliance with cGMP, EHS, and applicable regulatory requirements.
- Monitor labor and capital spending; recommend improvements to manufacturing policies, procedures, and programs.
- Provide guidance, support, and leadership to employees.
- Supervise daily production, scheduling, staffing, material management, compliance, training, and audits.
- Review and approve batch and system records; support product release timing goals.
- Ensure staff complete training on time and follow cGMP and EHS requirements.
- Lead simple process improvement projects; provide manufacturing input for new equipment/process integration and validation.
- Resolve technical/material/cGMP issues affecting deadlines; provide troubleshooting during deviations.
- Represent the company during FDA inspections.
- Conduct daily gemba walks; apply lean principles with ongoing coaching.
- Perform basic auditing tasks under supervision and troubleshoot simple problems.
Qualifications
- High School Diploma or GED with 5+ years related experience; or bachelor’s degree in science/engineering (or related technical field) with 2+ years related experience.
Required/Preferred Skills
- Ability to work across departments and contribute to team leadership.
- Strong verbal/written communication, teamwork, documentation, and customer service; safe performance under pressure.
- Understanding of cGMP and relevant regulatory requirements (pharmaceutical/medical industry).
- Continuous improvement process concepts (with support).
- Proficient in MS Word and MS Excel.
- FDA-regulated environment experience preferred.
Shift/Work Requirements (Important Considerations)
- Night Shift (C/D): 5:00 p.m.–5:30 a.m.; 2-2-3 rotating schedule.
- Work in controlled/clean environments with PPE; remove makeup/jewelry/contact lenses/nail polish/artificial fingernails.
- Work in cold/wet conditions; may work weekends/holidays and supplemental hours.
- Work around chemicals (e.g., alcohols, acids, buffers, Celite) that may require respiratory protection.
- Physical requirements: carry/lift/push/pull up to 30 lbs. (with assistance equipment); stand/walk extended periods across 8–12 hour shifts.
- Indoor working conditions; work around moving equipment; may be required to work in confined areas; some clean room and cool/hot storage conditions.