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Senior Quality Engineer / Principal Quality Engineer - Newark, DE - Global Operations

Plats Newark, Delaware, USA Jobb-id R-065525 Datum inlagd 11/09/2019

At AstraZeneca, we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Sr. Quality Engineer / Principal Quality Engineer in Newark, DE, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries, we’re focused on supplying our medicines with care, quality, and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

This is a multi-career level role and will be filled at either a Sr. Quality Engineer or Principal Engineer depending on the experience and capabilities of the successful candidate. The job responsibilities summarized and described in more detail below represent the full scope of the roles. The performance expectations at different career levels are also described.

Responsibilities:

  • Ensuring GMP compliance and operational effectiveness of the validation program (facility, equipment, utility qualifications; computer system validation, cleaning validation, or process validation).
  • Provide oversight/ownership of Validation related change controls, deviations, and related infrastructure activities within the Newark Operations site.
  • Responsible for ensuring compliance with GMP requirements during the design, construction, start-up, validation, and retirement (entire life-cycle) of capital project initiatives.
  • Provide oversight/ownership of other quality assurance programs and projects. These may include but are not limited to Product Containment and Quality Risk Management (QRM).
  • Cross-functional interaction with both internal and external colleagues in operations and QA to ensure full compliance with FDA and international GMP standards and regulations.
  • Influence stakeholders and partners and be able to effectively problem-solve complex quality assurance issues.
  • Identify evolving industry initiatives relating to validation oversight/related support systems and ensure the proactive involvement of Newark QA and site Operations.
  • Interfaces directly with the Newark Operations management team to provide advice and assist in resolving complex quality and compliance issues. Identifies and recommends solutions and new system controls.
  • Develops and maintains technical competence and collaborates with counterparts in engineering, maintenance, IT, QC and manufacturing to provide Quality oversight in designated projects and activities.
  • Interface with engineering, maintenance, IT, QC and manufacturing on capital projects and proactively ensure GMP compliance during the design, construction and start-up phases of these projects.
  • Supports quality assurance efforts for GMP related facility and equipment systems to ensure full GMP compliance.
  • Responsible for quality oversight of Continued Process Verification activities.
  • Supports Sr. Quality Director during internal site inspections and external regulatory inspections including interactions with regulators relative to site validation programs included minimally within this job description.
  • Support successful management of inspections.
  • Actively participate in outside industry and professional associations and influence these groups to adopt practices favorable to AZ. Provide insight into QA and the site in association with these interactions.
  • Participate in or lead project teams and programs that are related to the continuous improvement of validation oversight and related support systems (e.g. change control, preventative maintenance, risk assessment).
  • Core team participant on one or multiple regional or global teams such as Data Integrity, Quality Risk management, validation forums, and Issues Management Teams, driving resolution of complex compliance issues.
  • Participate in or lead the Site Risk Register program in conjunction with QRM.

Senior Quality Engineer:

  • Fully adept in multiple areas of qualification/validation with general knowledge of other areas of qualification/validation. The incumbent shall continue to increase specialized knowledge of additional validation areas.
  • May be the business process owner for the site process and will demonstrate a high level of proficiency in the primary process the individual manages.
  • Participates in cross-functional teams (site and regionally) and may lead projects, program implementations, and initiatives at the site level. They must consistently demonstrate the following:
  • Strong collaboration with the other regional and global sites to ensure consistent application of validation concepts, quality systems/processes across the site.
  • Self-motivated demonstrates leadership and works independently with minimal guidance from management.
  • High level of proficiency in problem-solving, creativity, independent thought, and sound judgment.
  • Influence in team and project meetings, advising project teams with respect to validation and quality solutions and potential new approaches for consideration.
  • Training and mentoring of others in the QA organization.
  • Strong performance history of consistently meeting and exceeding expectations will be expected over time to lead cross-functional / cross-regional teams.

Principal Quality Engineer:

  • Fully adept in multiple areas of qualification/validation with strong general knowledge of other areas of qualification/validation.
  • Thorough knowledge of formulation/packaging operations.
  • May participate and/or lead cross-functional teams (site and regionally) and may lead projects, program implementations and/or initiatives at the site level.
  • May be the business process owner for one or more site processes or a regional process. Demonstrates an expert level of proficiency in the primary process (s) they own.
  • May act as the quality representative/execution lead on major projects.
  • Consistently demonstrated the following:
  • Maintains current knowledge of regulatory and industry trends and actively communicates these to colleagues.
  • Identifies, leads and drives step-change improvements to validation business processes, quality systems and other processes they are engaged in through cross-functional project teams (site and regionally).
  • Expert level understanding of cGMPs, Validation and Quality Systems, specifically deviations and change controls.
  • Competency to provide back-up coverage for the Site Quality Lead as needed.
  • Strong influencing and negotiation at all levels of the organization to manage multiple stakeholders:
  • Mentor, train, and develop QA and other engineering/operations staff and interns in relevant technical subjects and is a key contributor to GMP training activities.
  • Supervision and oversight of contractors and intern activities.
  • Represent AstraZeneca interest in pharmaceuticals professional associations, discussion groups, etc.
  • Strong performance history of consistently meeting and exceeding expectations.

Senior Quality Engineer

Education:

  • BS in Chemical Engineering, Mechanical Engineering, Electrical Engineering, related Life Science, or related discipline with a minimum of five (5) or more years in GMP validation and / or quality assurance supporting pharmaceutical manufacturing systems.

Required:

  • Excellent oral and written communication skills with the ability to communicate effectively with individuals from all levels of the organization.
  • Strong knowledge of cGMPs and global GMP requirements, quality systems, and pharmaceutical manufacturing and/or packaging.
  • Strong knowledge of computer validation requirements and 21 CFR 11 requirements.
  • Strong knowledge of FDA and other relevant Regulatory agency policies/procedures
  • Strong familiarity with production operations.
  • Strong leadership, project management, and technical writing.
  • Strong interpersonal, communication, and influencing skills

Preferred:

  • Minimum of seven (7) years in Validation or QA in the pharmaceutical industry.
  • MS degree in a scientific discipline.
  • Understanding of pharmaceutical manufacturing equipment and controls, HVAC, purified water, and related utility systems.
  • Knowledge of lean / six sigma manufacturing training.
  • In-depth practical experience with typical electronic systems used for managing Quality data (e.g., Trackwise).

Principal Quality Engineer:

Education:

  • BS in Chemical Engineering, Mechanical Engineering, Electrical Engineering, related Life Science, or related discipline with a minimum of eight (8) or more years in GMP validation and/or quality assurance supporting pharmaceutical manufacturing systems with supervisory/management experience

Required:

  • Excellent oral and written communication skills with the ability to communicate effectively with individuals from all levels of the organization.
  • An advanced knowledge of cGMPs and global GMP requirements, quality systems, and pharmaceutical manufacturing and/or packaging.
  • In-depth practical experience with typical electronic systems used for managing Quality data (e.g., TrackWise).
  • Extensive knowledge of computer validation requirements and 21 CFR 11 requirements.
  • An advanced knowledge of FDA and other relevant Regulatory agency policies/procedures.
  • Well -developed interpersonal and problem-solving skills.
  • Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams in the US and global.

Preferred:

  • MS degree in a scientific discipline and/or Management.
  • ASQ Certification.
  • In-depth understanding of pharmaceutical manufacturing equipment and controls, HVAC, purified water, and related utility systems.
  • Lean / six sigma manufacturing training and applied experience.
  • In-depth experience with project management.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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