Duties/ResponsibilitiesThe Sr. Engineer I, Validation will play a critical 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 validation engineer with experience in GMP, an understanding of lab/manufacturing equipment, and a proven track record in validation processes.
- Establish validation protocols, risk assessments, and qualification plans to support GMP operations.
- Acts as a validation Subject Matter Expert (SME) providing support to multi-function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and strategies and defend their work before Health Authority inspectors and auditors.
- Executes multiple 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.
- Work collaboratively with peers within the cross-functional teams (Facilities and Engineering, IT, Manufacturing, Quality Control, Supply Chain, Quality Assurance, and Quality Engineering Validation) to manage workload to address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies.
- With minimal supervision, executes validation projects and tasks assigned and occasionally leads one or more projects within the validation area and contributes to more complex projects and initiatives for the broader site.
- Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
- Quickly learns from others and consistently steps up proactively. With some frequency, proactively supports other team members and helps them to be successful.
- Routinely seeks opportunities to learn BMS values. Excels in demonstrating one of the BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability) and works to address perceived deficiencies.
- Foster a culture of compliance, quality, and continuous improvement within the validation team.
- Stay abreast of all relevant GMP regulations, FDA guidelines, and international standards to ensure lab operations remain in full compliance.
- Interface with regulatory agencies during inspections and audits, serving as the subject matter expert for validation processes.
- Collaborate with cross-functional teams to address any findings related to validation and implement corrective actions as necessary.
- Oversee the qualification and validation of laboratory instruments, equipment, and systems, including but not limited to analytical instruments, autoclaves, and environmental monitoring systems.
- Implement risk-based validation approaches to optimize processes and reduce validation cycle times while maintaining the highest quality.
- Identify opportunities for process optimization and efficiency improvements within the validation function, collaborating with cross-functional teams as needed.
- Develop and deliver training programs for validation team members to enhance their capabilities and knowledge of validation principles and practices.
Qualifications- Bachelor's Degree in life sciences/engineering/STEM or equivalent years of experience
- 5+ years of commissioning, qualification, and validation (CQV) experience within technical and regulated industries
- Robust knowledge 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.
- Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry is beneficial.
- Experience and in-depth understanding 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.
- Excellent 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.
- Possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
- Experience in the Pharma/Biopharma required, cell therapy industry is plus.
- Detail oriented, with strong GMP, Validation and Engineering experience
- Experience utilizing regulatory knowledge to drive innovation and improvement in validation and engineering functions.
Compensation Overview:Bothell - WA - US: $107,000 - $129,656
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
