Development & Automation Engineer (all genders) Combination Products (perma

at  AbbVie

Unternehmensbeschreibung
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Stellenbeschreibung

QUALIFIKATIONEN

• BS or equivalent education and extensive, Typically, 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline
• Significant experience with quality strategies including qualification, validation, transfer
• Knowledge of ICH and ISO Guidelines, Good Manufacturing Practices (GMP), Design Controls, Good Documentation Practices (GDP), and FDA regulations
• Experience with Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian are preferred
• Documentation experience including technical reports, design verification plans, protocols, etc.
• Detailed understanding of principles and practice of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971), ISO 13485, 21 CFR Part 820, and ICH Q10
• Strong communication skills (both written and verbal) including the ability to influence without direct authority
• Knowledge of relevant regulatory requirements and guidelines, including FDA, EMA, and ISO standards
• Flexibility and adaptability to work in a dynamic and rapidly changing environment
• A keen eye for identifying project risks and proactively developing mitigation plans
• Experience with equipment including computer numerical control (CNC) and automated features is a plus
• Strong problem solving and analytical skills
• Strong understanding of engineering fundamentals
• Knowledge in basic statistics and Six Sigma statistical techniques is a plus
• Self-driver with proven track record of actively engaging and working in a matrixed environment with cross-functional teams and getting things done
• Other attributes include strong decision making, communication (spoken and written) skills, attention to details, and commitment to accuracyacos
  Zusätzliche Informationen

• Align strategy with all CPD sites and stakeholders of interface departments
• Global role: lead and guide quality improvement through all sites with matrix responsibilities and developing a quality data integrity concept
• Supervise: Ensure that equipment and combination products are designed in compliance with relevant regulatory requirements and guidelines, including FDA, EMA, and ISO standards
• Subject matter expert (SME): for tech transfer activities and method development for drug delivery devices, including experience developing and implementing process validation and control strategies. SME for local/global GMP and non-GMP test equipment including automated equipment selection used for combination product development and Design Verification testing
• Lab Support: Create and/or review test protocols and reports and supervise execution of exploratory and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams
• Design Verification: Author verification protocols and reports. Support investigations and issue resolutions
• Software Tools: Representative for Software evaluation and data integrity
• Complies with applicable policies and procedures, regulatory and safety requirements