Process Leader, Bio Production 2nd Shift Mon-Fri 3:00PM - 11:30PM

Boehringer Ingelheim•Saint Joseph, MI

About The Position

As an employee of Boehringer Ingelheim, the Process Leader contributes to the discovery, development, and delivery of products to patients and customers. The role provides technical direction and supervision in an assigned biological production area according to company policies and corporate business plans. It ensures workforce technical competence through appropriate selection and training, maintains a safe workplace, and implements and maintains compliance with cGMP and OSHA requirements. The role manages documentation flowing to and from the production floor, including batch records and equipment logbooks; supports continuous improvement; implements new technologies; and helps maintain low production costs. The Process Leader supervises, hires, trains, coaches, and develops departmental personnel; coordinates departmental activities and schedules; communicates departmental status and concerns to management; and may prepare or manage budgets, expenses, and capital projects. The role oversees operating-supply purchases, equipment recommendations, and production-area inventory cycle counts. It manages batch-record reviews and creates, reviews, and approves SOPs, controlled forms, and other business documents. It also tracks departmental KPIs and provides management with production, equipment, and personnel metrics and recommendations. The position analyzes production problems, documents findings, implements solutions, and investigates process deviations. It ensures compliance with applicable cGMP, APHIS, OSHA, EPA, EU, and JP regulations. It also directly performs, supervises, and supports production process steps to achieve safe, compliant, and reliable outcomes. The schedule is Monday through Friday, 3:00 PM to 11:30 PM.

Requirements

High school diploma required.
At least two years of professional experience in addition to a bachelor's degree, or six years of relevant experience in lieu of a degree; experience must include one year of leadership experience.
Demonstrated ability to train others and complete on-the-job training (OJT) assessments.
Ability to follow systematic continuous-improvement methodologies and identify, define, and implement process improvements.
Experience managing and auditing master receipts, batch records, and process-order data in relevant SAP/ERP software systems.
Experience with word processing, spreadsheets, and database management.
Detail-oriented, able to work with minimal supervision, and self-motivated in using resources to troubleshoot.
Ability to manage multiple ongoing projects with aggressive deadlines.
Strong proofreading skills and excellent communication and writing capabilities.
Proficiency in Microsoft Office applications such as Word, Excel, and Outlook.
Legally authorized to work in the United States without restriction.
Willingness to take a drug test and post-offer physical, if required.
Must be at least 18 years of age.

Nice To Haves

Bachelor's degree in a related business or scientific field preferred.
Experience with ERP inventory-control systems is preferred but not required.

Responsibilities

Provide technical direction and supervision in an assigned biological production area in accordance with company policies and business plans.
Select, train, hire, coach, and develop personnel; ensure workforce technical competence and a safe workplace.
Supervise personnel and communicate departmental status, concerns, issues, employee actions, ideas, and other relevant information to management.
Coordinate departmental activities and schedules.
Prepare or manage departmental budgets, monitor expenses, and manage capital projects.
Purchase operating supplies, recommend new or replacement equipment, and coordinate departmental cycle counts to control production-area inventory.
Manage production documentation, including batch records, equipment logbooks, and batch-record reviews for completed production items.
Create, review, and approve SOPs, controlled forms, and other documents supporting regulatory compliance, change controls, and company initiatives.
Maintain departmental KPI tracking and provide management with metrics and recommendations concerning personnel, equipment, and production trends.
Analyze production problems, document findings, implement solutions, and investigate production-process deviations.
Ensure compliance with cGMP, APHIS, OSHA, EPA, EU, and JP regulations applicable to production processes.
Perform, supervise, and support production process steps to ensure safe, compliant, and reliable outcomes.
Support continuous improvement, implement new technologies, and help maintain low production costs.