Senior CQV Engineer
Senior CQV Engineer
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Job Description
The Experience
At PSC Biotech it s about more than just a job it s about your career and your future.
Your Role
As a Senior CQV Engineer you will spearhead commissioning qualification and validation efforts for pharmaceutical facilities utilities equipment and systems. In this role youll take the lead in project planning execution and ensuring operational readiness of capital projects contributing directly to our clients success.
- Lead validation activities in a regulated pharmaceutical environment
- Oversee authoring reviewing and execution of validation documentation to ensure GxP compliance
- Provide technical leadership and mentorship to junior engineers
Key Responsibilities:
- Validation Execution & Oversight
- Lead execution of validation protocols and environmental mapping
- Ensure validation activities meet GMP and regulatory requirements
- Troubleshoot and resolve complex validation challenges
- Quality System Leadership
- Oversee Change Control Deviations and CAPAs
- Ensure timely completion of quality records and compliance with procedures
Training & System Management
- Manage Learning Management Systems (LMS) and Electronic Data Management Systems (EDMS)
- Provide training and mentorship to junior engineers and new hires
- Process Improvement & Strategy
- Drive continuous improvement initiatives within CQV processes
- Develop and implement validation strategies to enhance efficiency
- Collaboration & Stakeholder Engagement
- Work closely with cross-functional teams to ensure validation success
- Engage with external parties to align validation efforts with industry standards
- Metrics & Reporting
- Track and analyze Quality System Metrics
- Communicate trending data to leadership and regulatory bodies
Requirements
- Bachelor s degree in Chemical Engineering Biomedical Engineering or related field
- Minimum 7 years of experience in validation activities within GxP-regulated industries
- Proven ability to lead teams and mentor/train junior engineers
- Expert knowledge of cGMPs and biopharmaceutical/cell therapy regulations
- Strong understanding of facility/clean room design process equipment automation and validation
- Experience with start-up validation and licensure of new biopharmaceutical manufacturing facilities
- Proven ability to work with external parties and regulatory agencies
- Excellent verbal and written communication skills with the ability to influence at all levels
- Ability to prioritize tasks and provide clear direction in a dynamic environment
- Proficiency in MS Office Applications and ability to quickly learn new software programs
- Positive personality and solution-driven mindset
- Ability to excel in a fast-paced environment
- Must live in the Seattle area and be willing to work fully onsite
Benefits
Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
- Medical Dental and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
- Estimated annual salary (dependent on experience) $110000 $120000
Equal Opportunity Employment Statement:
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employer-sponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
#LI-RD1
Bachelor s degree in Chemical Engineering, Biomedical Engineering, or related field Minimum 7 years of experience in validation activities within GxP-regulated industries Proven ability to lead teams and mentor/train junior engineers Expert knowledge of cGMPs and biopharmaceutical/cell therapy regulations Strong understanding of facility/clean room design, process, equipment, automation, and validation Experience with start-up, validation, and licensure of new biopharmaceutical manufacturing facilities Proven ability to work with external parties and regulatory agencies Excellent verbal and written communication skills with the ability to influence at all levels Ability to prioritize tasks and provide clear direction in a dynamic environment Proficiency in MS Office Applications and ability to quickly learn new software programs Positive personality and solution-driven mindset Ability to excel in a fast-paced environment Must live in the Seattle area and be willing to work fully onsite
Education
Bachelor s degree in Chemical Engineering, Biomedical Engineering, or related field
Employment Type
Full Time
