Validation Associate Engineer Bothell - WA - US R1604052 Posted ago

Position: Validation Associate Engineer Bothell - WA - US R1604052 Posted 19 hours ago
## Validation Associate Engineer Bothell - WA - USFind out how well you match with this job
** Working with Us
** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:  Validation Associate Engineer will play a significant role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility.

This position requires a hands-on individual with experience in GMP, an understanding of laboratory and/or manufacturing equipment, and strong technical writing and problem solving skills.  
** Key Responsibilities
*** Support the Periodic Review and Periodic Requalification program at BMS sites in Bothell, WA and Seattle, WA, including execution of requalification activities (temperature mapping studies), and development of Periodic Reviews.
* With oversight, generate validation protocols, specifications, reports, and qualification plans to support GMP operations.
* Perform Validation Impact Assessments for on demand work orders of qualified equipment, utilities, and facilities.
* Supports execution of projects that require qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverable per approved validation plans under direction of a more senior Validation Engineer.
* Work collaboratively with peers within the cross-functional teams (Facilities and Engineering, Information Technology, Manufacturing, Quality Control, Supply Chain, Quality Assurance, and Quality Engineering Validation) to support projects and qualification work.
* Quickly learns from others and consistently steps up proactively. With some frequency, proactively supports other Validation team members and helps them to be successful.
* Routinely seeks opportunities to learn and practice BMS values. Demonstrates the BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, and Accountability) and works to address perceived deficiencies.
** Qualifications & Experience*
* * Bachelor’s Degree in life sciences/engineering/STEM or equivalent
* 2 years of experience in a GMP setting, preferably pharmaceutical manufacturing operations or support.
* Experience or exposure with commissioning, qualification, and validation (CQV) within technical and regulated industries is recommended.
* Awareness of cGMP, GDP, GXP, GAMP5 regulations, including 21

CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data integrity requirements
* Experience with equipment/utility/facility qualifications and general commissioning, qualification and validation CQV practices is beneficial.
* Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry is beneficial.
* Experience of validation lifecycle deliverables and documents from equipment design through qualification (starting with URS, to the end of IQ/OQ/PQ and SR) and computer system validation (CSV) documents through system retirement is beneficial.
* Strong project and program management, communication skills, and technical writing skills are required.
* Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents are desired.
* If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we…