Validation Associate Engineer

Bristol Myers Squibb•Bothell, WA

1d•$83,220 - $100,847•Onsite

About The Position

The 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.

Requirements

Bachelor’s Degree in life sciences/engineering/STEM or equivalent
2 years of experience in a GMP setting, preferably pharmaceutical manufacturing operations or support.
Strong project and program management, communication skills, and technical writing skills are required.

Nice To Haves

Experience or exposure with commissioning, qualification, and validation (CQV) within technical and regulated industries is recommended.
Awareness of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR 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.
Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents are desired.

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.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
unlimited paid sick time
up to 2 paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
an annual Global Shutdown between Christmas and New Years Day.