Validation Engineer応募後で応募 求人ID R0021855 掲載日 08/07/2020 Location:Brooklyn Park, Minnesota
Are you looking for a patient-focused,innovation-driven company that will inspireyou and empower you to shine? Join us as a Validation Engineer in our Brooklyn Park office.
- Support one or more validation disciplines (e.g., cleaning, computerizes systems, sterilization) at a multi-product biologics facility using a risk-based approach.
- Participate in multi-disciplinary teams in the implementation of validation activities. Author and execute protocols, final reports, procedures, and other documents as necessary.
- Represent Takeda during regulatory, corporate, division and third-party inspections; defend the validation program(s) to auditors and inspectors; support regulatory submission processes as required.
- Own and/or author controlled, and uncontrolled documentation associated with assigned validation discipline(s); maintain and improve this documentation as necessary to maintain compliance to government regulations, internal corporate requirements, current industry practices, business needs, and current industry best-practices.
- Develop and execute studies, commissioning and validation protocols. Assist in deviation resolution, summarize results, and author final reports. Plan and manage protocol execution, and coordinate with other departments as necessary.
- Support investigation and change control processes when needed.
- Complete mandatory training within required timeframe.
- Perform other duties as assigned.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Preferred Combination of Education and Experience:
- A minimum of a BA or BS in chemical, mechanical, industrial or electrical engineering; alternatively, a combination of military and industry experience and training is acceptable.
- Other degrees, such as a BA or BS in biology, chemistry, math, molecular biology and/or other life science, are acceptable if the candidate has relevant experience (e.g. education or employment in sciences or validation).
- At least two (2) to four (4) years of relevant experience within a Validation, Engineering, Technical Services, and/or Manufacturing role in the pharmaceutical, medical device, biotechnology and/or biopharmaceutical industries.
- With a graduate degree, or relevant training and experience, at least zero (0) to two (2) years of relevant experience within a Validation, Engineering, Technical Services, and/or Manufacturing role is required.
Knowledge, competencies and skills:
- Excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
- Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Ability to manage and prioritize multiple activities concurrently.
- Proficient in Microsoft Word and Excel, Project and other desktop computing software.
- Experience with protocol development and execution, deviation identification and resolution, and summary/final report authoring. Experience performing statistical analysis of validation test results.
- Familiar with/experience in protein purification from cell culture processes. Understanding of biochemical and microbiological methods supporting the product line.
- Project management experience
- Previous validation experience in Rockwell Automation, FTView SE, ControlLogix, FTBatch, SQL Databases and OSI Pi as well as lab equipment and software such as QC LIMS and Empower, building automation, and IT infrastructure preferred.
- Considered a validation Subject Matter Expert (SME) in one or more areas of plant automation and process control systems, QC Chemistry and microbiology systems, metrology business systems and IT infrastructure.
- Expertise in Software Development Life Cycle (SDLC), 21 CFR Part 11, EU's Annex 11, and GAMP® 5 requirements desirable.
- Experience with moist-heat sanitization/sterilization cycle qualification and understanding of current regulatory and industry guidelines.
- Demonstrated ability to comprehend mechanical/electrical drawings and related engineering prints for CQV activities.
- In general, the position requires a combination of sedentary work and walking around the cGMP manufacturing facility.
- May occasionally work in a clean room environment and wear special garments and personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.
- May be required to travel - less than 15%
Brooklyn Park, MN