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Description
This position provides technical direction and supervision in their assigned biological production area according to company policies and corporate business plans, to provide technical competence through proper selection and training the work force, to ensure a safe work place through proper training of the work force and to implement and maintain compliance status (cGMP, OSHA) within the department. Manages the documentation flowing in/out of the production floor including, but not limited to, batch records, equipment logbooks, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
This shift will work 4-10hour periods Friday, Saturday, Sunday, Monday
Duties & Responsibilities
Supervise personnel to include communicating to management the status and/or progress of departmental concerns, issues, employee actions, new ideas, and all other relevant information to ensure success within the department. Hire, train, coach and develop personnel within the department in accordance with policies and procedures.
Coordinate the activities and schedules of the department.
Prepare and/or manage departmental budget and monitor departmental expenses and capital projects. Responsible for purchase of operating supplies to include recommendations new or replacement equipment. Coordination of cycle counts in the Department to control inventory in production areas.
Accurate business function documentation management: Organize/prioritize batch record reviews as defined by Management for completed production items.
Assist in the creation, review and approval relevant SOPs, Controlled Forms and other business function documents to support regulatory compliance, change controls and company driven initiatives.
Manage and maintain tracking system for department key performance indicators. Provide data/metrics to Management regarding individual, equipment, production trends; provide recommendations to resolve errors.
Troubleshoot production problems, document findings, and implement solutions to resolve problems
Investigate production process deviations.
Ensure compliance with cGMP, APHIS, OSHA, EPA, EU, and JP regulations pertaining to production process.
Team Leader Requirements
Bachelor´s Degree in related business or scientific field from an accredited institution.
In addition to Bachelor´s degree, two (2) years of professional experience.
In lieu of a degree, six (6) years of relevant experience.
Experience must be inclusive of one (1) year of leadership experience.
Experience must be inclusive of managing and auditing master receipts, batch records and process order data within relevant SAP/ERP software systems.
Experience in ERP inventory control system(s) is preferred but not necessary.
Experience with word processing, spreadsheets, and database management required.
Demonstrated ability to train others and complete OJT assessments.
Demonstrates the ability to follow systematic continuous improvement methodologies and the willingness to identify, define, and implement process improvements.
Demonstrated knowledge of Aseptic or related production techniques and equipment.
A working knowledge of cGMP, EU and OSHA Part 11 guidelines as they pertain to implementing process improvements on aseptic production or other production equipment.
Must be detail oriented, able to work with minimal supervision and self-motivated to utilize resources to troubleshoot as needed.
Ability to manage multiple on-going projects with aggressive deadlines.
Strong proofreading skills along with excellent communication and written capabilities.
Must be proficient in MS office applications such as Word, Excel, Outlook, etc.
Must be able to readily learn and quickly become proficient in all software applications utilized for packaging equipment and operations.
Group Leader Requirements
Bachelor´s Degree in related business or scientific field from an accredited institution and a minimum of four (4) years of experience in cGMP Aseptic production, Bio manufacturing, pharmaceutical or similar manufacturing environment.
In lieu of a Bachelor´s degree, a minimum of ten (10) years of experience in cGMP Aseptic production, Bio manufacturing, pharmaceutical or similar manufacturing environment can be utilized.
Experience must be inclusive at least three (3) years leading people and/or moderate to complex process improvement and related production projects.
Experience must be inclusive of managing and auditing master receipts, batch records and process order data within relevant SAP/ERP software systems.
Experience with word processing, spreadsheets, and database management required.
Experience in ERP inventory control system(s) is preferred but not necessary.
Demonstrated ability to train others and complete OJT assessments.
Demonstrates the ability to follow systematic continuous improvement methodologies and the willingness to identify, define, and implement process improvements.
Demonstrated knowledge of Aseptic or related production techniques and equipment.
A working knowledge of cGMP, EU and OSHA Part 11 guidelines as they pertain to implementing process improvements on aseptic production or other production equipment.
Must be detail oriented, able to work with minimal supervision and self-motivated to utilize resources to troubleshoot as needed.
Ability to manage multiple on-going projects with aggressive deadlines.
Strong proofreading skills along with excellent communication and written capabilities.
Must be proficient in MS office applications such as Word, Excel, Outlook, etc.
Must be able to readily learn and quickly become proficient in all software applications utilized for packaging equipment and operations.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.