BioLife Solutions is repeatedly named one of Washington’s 100 Best Companies to Work For, a list curated by Seattle Business Magazine. We welcome you to apply to join our dynamic, high-energy team. Here you will find a performance-based, family-oriented environment where authentic communication and treating colleagues with respect are required. Our employees receive a competitive benefits package, which includes generous company stock awards and a 401k matching program.
BioLife Solutions is a leading developer, manufacturer and supplier of class-defining cell and gene therapy bioproduction tools and services. Our solutions facilitate basic and applied research and commercialization of new therapies by maintaining the health of biologic source material and finished products during manufacturing, storage, and distribution. Our solutions offer commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of biologic materials. Our tools portfolio includes our proprietary, serum-free and protein-free, fully defined CryoStor® freeze media and HypoThermosol® shipping and storage media, ThawSTAR® family of automated, water-free thawing products, evo® cold chain management system, and Custom Biogenic Systems high-capacity storage freezers. Services include SciSafe biologic and pharmaceutical materials storage. For more information, please visit: www.biolifesolutions.com.
General Summary and Purpose:
The Senior Maintenance and Validation Technician is a core team member of the Facility and Equipment Operations (FAC) team. The Senior Maintenance and Validation Technician role will support day-to-day tasks and ongoing projects to make BioLife Solutions and their business successful.
Some of the key traits, but not limited to are:
Assisting with ongoing projects, Supporting BioLife internal & external customers, and constantly improving the FAC team. The role will perform all functions in compliance with Company Policies and Quality Systems.
Duties and Responsibilities:
- Leads/Oversees maintenance of equipment records system to support the GMP compliant cleanrooms and
laboratories.
- Revises equipment Standard Operating Procedures (SOP)
- Schedules equipment service calls and regular calibrations performed by external service providers.
- Assist/Lead/Drive Cleanroom maintenance programs in accordance with our internal customers.
- Assist/Lead/Drive FAC department mini projects in accordance with stakeholders and desired outcome.
- Oversees and verifies that external service providers perform maintenance in line with internal and regulatory
requirements.
- Support site service activities and requests. By providing service and documenting actions and updating team
members.
- Interfaces with manufacturing/QC/logistics staff to schedule and perform equipment maintenance.
- Performs equipment relocations and Final Acceptance Test (FAT) of more complicated equipment.
- Performs equipment installations, required calibrations, and routine maintenance.
- Troubleshoots, track, and document to resolution emergent equipment issues to prevent delays to in-progress
production.
- Performs equipment repairs or facilitates repair by an external service provider.
- Write or revise equipment and facilities qualification documents (IQ/OQ/PQ)
- Perform or oversees execution of equipment and facilities qualifications (IQ/OQ/PQ)
- Author QMS investigations and design of CAPA plans
- Implement CAPA plans.
- Track, trend, and analyze department metrics and KPIs. Propose continuous improvement projects based on
analyzing department data.
- Conducts sourcing, on-boarding, and commissioning of equipment in conjunction with head of Facilities and
departmental SMEs.
- Must be able to support off hours; evenings and weekends when tasks dictate the need.
- Assists in training and oversight of Maintenance and Validation Technician I & II team members.
- On call after hours to respond to equipment monitoring system alarms.
- Cross train with all BioLife platforms production and servicing.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or
responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time
with or without notice.
Job Requirements:
- Able to lead projects independently. Be able to translate trouble shooting into standard work.
- Detail oriented.
- Strong written and verbal communication skills
- Organizational and multi-tasking skills
- Results driven and adaptable to irregular non-frequent events.
- Strong technical/troubleshooting skills
- Positive attitude, flexibility, and willingness to learn and work in a team environment.
Job Specifications:
- Cleanroom experience preferred, but not mandatory.
- 5+ years cGMP facility or equipment lifecycle management experience.
- 2 years equipment validation experience
- Experience with working on projects and meeting deadlines for the success of the overall team.
- Experience with creating and updating product build work instructions (WI).
- NPI experience a plus.
- Associate degree (experience can be applied in leu of education)
- CMRP certification a plus
- Experience with CAPA and Change Control systems and management
- Proficient in Microsoft Office
- Must be able to lift up to 55 pounds at a time
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BioLife Solutions is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
BioLife Solutions provides a substance-free workplace, and all offers of employment will be contingent on opiate drug test and background check.
The US base salary range for this position at full-time is $73,542 - $110,313 per year. Our salary ranges are determined by position, level, location, and market competitive benchmarks. Individual pay within a level is determined by work location (including geographic pay zone region), job related skills, experience, education, and training.
The BioLife Solutions total rewards program includes, but is not limited to medical, dental, vision, 401K with generous match, life and disability insurance as well as time off programs of Vacation and Sick time. Additionally, we believe in our team members sharing the success of our business and therefore we may provide cash bonus or stock equity grants based on company performance as a part of our total rewards package.
