Sr. Quality Engineer, Validation - Marlborough, MA | Biospace
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Sr. Quality Engineer, Validation


Marlborough, MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description


The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and is focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.


AIRM is seeking a highly motivated individual to join us as a Sr. Quality Engineer, Validation. This member of the quality systems team will facilitate phase-appropriate Validation deliverables and programs as AIRM moves through clinical trials and commercialization. The successful candidate will foster compliance across a broad range of Validation and equipment compliance topics beginning with equipment and facility qualification/requalification, and will be prepared to build and lead the AIRM Validation team moving forward.
The Sr. Quality Engineer, Validation reports to a Quality Assurance Manager, who in turn reports to the Senior Director of Quality Assurance. Quality Assurance forms one element of the organization's Technical Operations team, complementing and joined by Manufacturing, Quality Control, Engineering, Product Development, and Translational Development.

Essential Responsibilities

* Coordinates the development, deployment, and execution of Validation programs, procedures, and practices at AIRM, ensuring compliance with relevant international industry standards.
* Serves as manager and lead executor for cross-functional, Validation-related efforts, developing appropriate plans, schedules, resource loading and other project deliverables as required.
* Authors, executes, and/or oversees the contracting of validation protocols and cleanroom certification/recertification efforts. Writes final summary reports and interacts with the Change Control as necessary. Reviews and approves validation protocols and reports provided by contract services or junior staff.
* Builds, manages, and reports on the time-based equipment requalification program, ensuring that critical equipment receives timely and compliant reevaluation.
* Manages multiple projects and ongoing activities while maintaining control, organization, GMP compliance, and adherence to good documentation and archival practices in the validation function. Demonstrates initiative by identifying unaddressed issues, undertaking additional responsibilities, and responding to events as they arise with little or no supervision.
* This position will provide a direct and positive impact on the compliance of the equipment, facility, methods, and systems supporting current and future AIRM manufacturing processes. AIRM processes will be compliant with the strictest international regulatory standards and meet Astellas' uncompromising focus on Quality and Integrity.
* The successful candidate will ensure that the AIRM fleet of temperature-controlled chambers, biosafety cabinets, analytical instruments, utilities, computer systems, cleanrooms, and processes achieve and maintain inspection readiness and are prepared to provide the highest-quality products to AIRM patients.

Supervisory Responsibilities

* Supervises a team of more junior Validation specialists and/or contract validation service providers. Identifies and builds a small team of in-house Validation professionals, developing their skills and abilities through sound mentorship and coaching. Develops healthy business relationships with critical contract service providers to supplement AIRM talent as needed.
* Coordinates prioritization of activities with area management and independently executes established priorities per organizational needs and the Validation Master Plan.
* Functions as a technical stakeholder and key opinion leader on validation-related topics: equipment control, aseptic processing compliance, computer system compliance, building monitoring system (BMS) management, cold-chain logistics, container closure, method qualification, sterilization topics, and risk assessments related to these areas.
* Monitors compliance of assigned responsibilities, trends failures, evaluates effectiveness of corrective actions. Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.
* Represents functional area during regulatory inspections, internal and mock audits, and customer activities. Participates in inspection readiness activities as a core member.
* Participates in Astellas' performance management program by establishing goals, tracking progress, developing competencies, and evaluating progress of future subordinate team members.



* BS or BA in Engineering, Chemistry, or Life Sciences with typically 6+ years of related experience within the field; typically 3+ years with Master's degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 9+ years of relevant industry experience in biotechnological and/or pharmaceutical manufacturing, validation, and/or quality engineering.
* Ability to interpret regulatory rules, guidance, and normative industry to make objective, risk-based decisions and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management and providing business justifications and cost estimates where applicable.
* Working fluency with Adobe Acrobat, the entire Microsoft Office productivity suite (including Visio), and the Kaye Validator data acquisition system. In particular, Microsoft Excel competency will be evaluated.
* Demonstrated knowledge of cGMP for biotechnology, validation-related topics, and key industry validation approaches (e.g., validation lifecycle approach, ASTM E2500, GAMP 5, V-model, etc.). Complementary knowledge of biopharmaceutical and process engineering principles and practices.
* Working understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements is critical.
* Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert.
* Ability and willingness to work within a high-performing team and collaborate effectively and respectfully with staff at all levels and of diverse backgrounds.
* Previous experience in a Supervisory or Lead position
* Experience using and fluency with Microsoft Project or similar project management /scheduling tools
* Advanced proficiency with MS Excel, MS Word
* Knowledge of basic database design and reporting principles; experience with MS Access, SQL, Oracle, Crystal Reports, etc.
* Specialized knowledge of any industry-related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.
* ASQ certifications (e.g., certified quality engineer, quality auditor, manager of quality / organizational excellence, etc.)


The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.

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