The Process / Validation Engineer will perform activities for the development and qualification of materials and or technical service providers. All Engineering activities must be in compliance with FDA, GMP, ISO and Corporate Quality System regulations.
Specific Tactical Responsibilities:
- Participate in / lead project teams in the identification, development, qualification and implementation of materials for commercialized products to meet the supply chain needs of the business.
- Support selection of materials for cGMP production
- Provide technical assessments on change controls assessing proposed changes to qualified materials to identify requirements necessary to maintain qualified status
- Perform qualifications of materials including protocol generation execution, data analysis and compilation of data and results into summary and final report.
- Excellent verbal communication to all levels of the organization, suppliers, external labs.
- Excellent written communications skills
- Ability to express complex scientific principles in a clear, concise and consistent way
- Perform activities required to support qualifying suppliers per company Approved Supplier Program.
- Maintain detailed documentation throughout all phases of development through qualification and implementation.
- Maintain current design control documentation meeting requirements and industry standards
- Other projects and activities as required
The job requires the ability to act on problems of diverse and highly technical scope, requiring critical thinking and interaction with internal and external technical, supply chain and production professionals. The position exercises broad judgment within generally defined practices and policies and exercises analytical decision-making abilities.
No direct reports, however, must be able to participate in multi-disciplined project teams.
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Material Engineering or related field.
- Minimum 5 years of experience in a medical device or pharmaceutical industry in a material / process qualification role.
- Experience on how to qualify and validate raw materials / critical suppliers in FDA regulated environments.
- Experience in design and specification requirements for raw materials and components for medical device and pharmaceutical industries
- Broad knowledge and experience with the FDA / ISO standards, regulations and qualification requirements for commercialized medical device / pharma products.
Desired Experience, Knowledge, and Skills:
- Specific knowledge and experience qualifying container closure for injectable products in medical device and pharma industry (Container closure integrity, E&L, biocompatibility, Aseptic process simulations, autoclave validations).
- Experience qualifying suppliers and processes related to internal and external terminal sterilization of medical devices (Autoclave, Media Fills, Gamma, ETO).
- Experienced in leading projects to completion. Demonstrated ability to network effectively and collaborate with others. Ability to manage multiple projects proficiently.
- Experience leading and owning engineering change controls related to material or process changes.
- Strong analytical and organizational skills
- Proactive problem definition and creative problem-solving skills