Production Operations Group Lead - Day Shift
Takeda
June 26, 2026
On-site
Round Lake Beach, IL
$71,800 - $112,860 USD yearly
Operations
Production Operations Group Lead (Night Shift) — Round Lake, IL
Responsibilities:
- Supervise initial inspection, pasteurization, and incubator production activities to achieve manufacturing goals while maintaining compliance with cGMP, EHS, and applicable regulatory requirements.
- Monitor labor and capital spending; recommend manufacturing process/policy improvements.
- Provide daily leadership and guidance to employees.
- Supervise daily production, scheduling, staffing, material management, training, compliance, and audits to meet deadlines and quality standards.
- Review/approve batch and system records; support product release timing goals.
- Ensure staff complete training on time and follow cGMP/EHS processes.
- Lead simple process improvement projects; provide input for new equipment/process integration and validation.
- Resolve technical/material/cGMP issues impacting deadlines; troubleshoot during process deviations.
- Represent the company during FDA inspections; conduct daily gemba walks.
- Apply lean principles with coaching; perform basic auditing tasks under supervision; troubleshoot simple problems with coaching.
Qualifications:
- High School Diploma/GED with 5+ years related experience, or Bachelor’s degree in science/engineering/related technical field with 2+ years related experience.
- Ability to work across departments and contribute to team leadership.
- Strong communication and documentation skills.
- Understanding of cGMP and relevant regulatory requirements.
- Ability to apply Continuous Improvement Process concepts with support.
- Proficient in MS Word and MS Excel.
- Experience in an FDA-regulated environment (preferred).
Important considerations (work conditions/physical):
- Controlled manufacturing environment (special gowning/protective clothing); cold/wet conditions; possible weekends/holidays and supplemental hours.
- Remove makeup/jewelry/contact lenses/nail polish/artificial fingernails in manufacturing areas.
- Work around chemicals (may require respiratory protection).
- Lift/carry/push/pull up to 30 lbs (with assistance for pushing/pulling).
- Stand/walk for extended periods (8–12 hour shift).
- Indoor conditions, moving equipment/machinery, possible confined areas; some clean room and cool/hot storage conditions.
Night shift assignment: A/B (5:00 a.m.–5:30 p.m.), 2-2-3 rotating schedule.
Responsibilities:
- Supervise initial inspection, pasteurization, and incubator production activities to achieve manufacturing goals while maintaining compliance with cGMP, EHS, and applicable regulatory requirements.
- Monitor labor and capital spending; recommend manufacturing process/policy improvements.
- Provide daily leadership and guidance to employees.
- Supervise daily production, scheduling, staffing, material management, training, compliance, and audits to meet deadlines and quality standards.
- Review/approve batch and system records; support product release timing goals.
- Ensure staff complete training on time and follow cGMP/EHS processes.
- Lead simple process improvement projects; provide input for new equipment/process integration and validation.
- Resolve technical/material/cGMP issues impacting deadlines; troubleshoot during process deviations.
- Represent the company during FDA inspections; conduct daily gemba walks.
- Apply lean principles with coaching; perform basic auditing tasks under supervision; troubleshoot simple problems with coaching.
Qualifications:
- High School Diploma/GED with 5+ years related experience, or Bachelor’s degree in science/engineering/related technical field with 2+ years related experience.
- Ability to work across departments and contribute to team leadership.
- Strong communication and documentation skills.
- Understanding of cGMP and relevant regulatory requirements.
- Ability to apply Continuous Improvement Process concepts with support.
- Proficient in MS Word and MS Excel.
- Experience in an FDA-regulated environment (preferred).
Important considerations (work conditions/physical):
- Controlled manufacturing environment (special gowning/protective clothing); cold/wet conditions; possible weekends/holidays and supplemental hours.
- Remove makeup/jewelry/contact lenses/nail polish/artificial fingernails in manufacturing areas.
- Work around chemicals (may require respiratory protection).
- Lift/carry/push/pull up to 30 lbs (with assistance for pushing/pulling).
- Stand/walk for extended periods (8–12 hour shift).
- Indoor conditions, moving equipment/machinery, possible confined areas; some clean room and cool/hot storage conditions.
Night shift assignment: A/B (5:00 a.m.–5:30 p.m.), 2-2-3 rotating schedule.