
Description
Responsible for the process, cleaning and equipment validation activities and documentation for the manufacturing and packaging area, including providing technical support to day-to-day operations. Ensure that the manufacturing and packaging area validation state is sustained and in compliance. 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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
- Manages the cleaning validation system for manufacturing and packaging product contact areas.
- Generates protocols and reports, coordinates validation activities with areas, and executes cleaning validation processes.
- Manages the change control system for GMP and non GMP changes at the site.
- Provide support to system users.
- Performs the revision of the change control system procedures.
- Conducts training of documents to personnel.
- Performs cleaning impact assessments for new and/or modified equipment.
- Manages the process validation system for the manufacturing area.
- Generates protocols and reports, coordinates validation activities with areas, and executes process validation processes.
- Conduct special studies to support operations as required.
- Manages process changes, supplier changes for active ingredient (API), and raw materials changes for the manufacturing products.
- Performs the revision of cleaning and process validation standard operating procedures.
- Conducts training of personnel in revised documents.
- Provides technical expertise and support to manufacturing and packaging investigations in order to identify root causes on deviations, corrective and preventive actions, and for assessing product impact and impact on process and/or cleaning validated status, as needed.
- Conducts investigations on deviations to the cleaning validation, process validation and change management system, including the identification of root causes, CAPAs and the submission of deviation reports.
- Performs continuous process verification (CPV) for manufacturing product validated process to ensure sustainment of the validated state.
- Develops annual cleaning review to ensure that the cleaning process for the manufacturing products remains in a validated state.
- Provides day-to-day technical support to the manufacturing and packaging area.
- Troubleshot process and equipment deviations.
- Generate and implement process and equipment improvements.
- Assists in regulatory audits providing technical support, data and documentation.
- Reviews and approves changes to manufacturing batch records and cleaning batch records to ensure their alignment to the validated processes.
- Provides guidance, generate, review and/or approve packaging component changes, packaging component specifications, and packaging component bill of materials.
- Review and approve laboratory in-process books.
- Complies with all safety and environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any safety and environmental events.
- Performs other job-related tasks and/or projects as required.
Requirements
- Bachelor degree in Engineering.
- At least five (5) years of experience in pharmaceutical manufacturing or technical operations in manufacturing.
- PR engineer license - EIT or PE - is preferred, but not required.
- Statistic knowledge to analyze data, identify patterns, make assumptions that drive decision-making.
- Knowledge and skills of Lean Six Sigma is highly preferred.
- Experience with Office (Excel, Power Point, Word, Outlook, Project Manager).
- Strong knowledge of cGMPs and quality standards (including process and cleaning validation) related to pharmaceutical manufacturing.
- Proven technical writing skills.
- Project management skills.
- Presentation and training skills.
- Communication skills in Spanish and English (technical), written and verbal.
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
Desired Skills, Experience and Abilities
- Experience working in SAP environment is highly desired.
- Knowledge of statistical software is desired.