Avantor, Inc. Senior Quality Engineer in Devens, Massachusetts
Job SummaryAvantor is setting science in motion to create a better world. BioPharma is the fastest growing segment of the Avantor business. Therefore, we seek talented business professionals are needed who can successfully operate in a dynamic fast-growing environment. The Sr Quality Engineer will drive initiatives to best in class quality and regulatory practices.
The Senior Quality Engineer leads efforts to improve global quality and regulatory processes, systems, and data. He/she is responsible for identifying and implementing programs to ensure compliance with cGMPs, ICH, IPEC, ISO, FDA, and life science industry expectations.
This role is also responsible to be a subject matter expert for the following topics: Risk Management, Quality Management Systems, Life science industry regulations, Q Metrics and KPI’s, Digital QMS tools, Change management, Data management, ISO and cGMP, Aseptic processing, Continuous improvement.
MAJOR JOB DUTIES AND RESPONSIBILITIES:
Lead or support global process improvement projects. Must be comfortable: Influencing and driving change, Leveraging the matrix environment, Navigating through technical and non-technical complexity, Engaging with customers directly on quality topics, Collaborating with business partners and leaders
Lead programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirements
Drive improvement efforts with specific focus on, supplier compliance data management, environmental monitoring, cleanroom validation, sterility validation, site expansions and product transfers
Provide support for acquisition/merger, advising on process and system integration.
Perform statistical analysis regarding process data, trends, product and process development, and validation.
Design and implement system for material data management.
Collaborate with cross functional partners to investigate and resolve process and product compliance issues.
Lead or support the development of quality and regulatory policies, processes, and procedures.
Lead and/or support initiatives to implement or improve business, quality and regulatory processes. These initiatives good range from core Q/R process, data management, KPI trends, electronic systems, and services to business, manufacturing, and commercial.
Lead and support aspects of implementing a global quality management system.
Establish quality KPI’s for the global network. And drive improvement efforts based on the KPI trends.
Provide guidance to management staff on the integration of FDA regulations, ISO standards, and industry expectations into the Quality Management System (QMS).
Participate in industry groups (BPOG/BPSA, ISPE, Rx360) representing Avantor.
Utilize and foster Lean, Six Sigma, and other continuous improvement methodologies.
Interface with multiple sites, functions, and leaders.
Assist in validation processes including TM validation, manufacturing process validation, cleaning validation.
Bachelor’s Degree in a science-related discipline (engineering, biology, microbiology, materials, chemistry, etc..)
Minimum of five (5) years of experience in quality engineering or a related role required
Experience working within pharmaceutical, biotechnology and/or chemical environments required
ASQ Certified Quality Engineer, or are currently pursuing certification is preferred.
KNOWLEDGE SKILLS AND ABILITIES:
Knowledge of ISO 9000/ AS9100.
Working knowledge and experience with LEAN, Six Sigma methodologies.
Working knowledge in Design of Experiments (DOE), and ability to manage implementation of improvements.
Proficiency working with Microsoft Excel, Word.
Experience with Minitab or other statistical software strongly desirable.
Understanding of statistical process and quality control principle.
Ability to work effectively in a team environment.
Ability to identify problems and communicate solutions in a constructive and positive manner.
Attention to detail; excellent organizational and record keeping skills.
DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Avantor is proud to be an equal opportunity employer.
We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at TalentManagement@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision using the links below.
EEO is the Law (https://media.vwr.com/emdocs/docs/EEO-is-the-law.pdf)
OFCCP EEO Supplement (https://media.vwr.com/emdocs/docs/OFCCP-EEO-Supplement.pdf)
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
3rd party non-solicitation policy
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation
Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world. For information visit, www.avantorsciences.com and find us on LinkedIn (https://www.linkedin.com/company/avantorinc/) , Twitter (https://twitter.com/Avantor_News) and Facebook (https://www.facebook.com/Avantorinc/) .
- Avantor, Inc. Jobs