Validation Engineer

Bristol Myers Squibb • Bothell, WA

1d • $95,130 - $115,278 • Onsite

About The Position

The Validation 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
• 4 years of experience in a GMP setting - preferably within the Pharma/BioPharma industry.
• Minimum of 3 years of commissioning, qualification, and validation (CQV) experience within technical and regulated industries.
• 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 are required.
• Strong project and program management, communication skills, and technical writing skills are required.

Nice To Haves

• 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 as a point of contact for project stakeholders.
• Executes validation projects and tasks assigned and occasionally leads one or more projects within the Validation department.
• 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

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 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.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level