Role Overview We are seeking a
Facilities Engineer II to lead the implementation of new assets through the validation process and/or requalifying assets ensure all validation deliverables and regulations have been met, technically support cGMP Manufacturing and GxP operations with equipment issues, and manage Facility projects, as necessary.
Schedule: Monday to Friday; 8:00 am - 5:00 pm; on-call support as needed
Reports to: Director, Facilities, Engineering, & Asset Lifecycle
Location: 13203 Murphy Road Suite 100 Stafford, TX 77477
Basic Qualifications: - Bachelors degree in Biotechnology, Mechanical, Electrical, Chemical Engineering, or related field
- 5+ years in pharmaceutical or biotech engineering within a GxP regulated manufacturing or laboratory environment
Preferred Qualifications: - Demonstrated knowledge of FDA and cGMP requirements
- Applied experience in good documentation practices and data integrity principles.
- An understanding of 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, EU Annex 1, and USP
- Experience in writing and reviewing Deviations and CAPAs, investigations resulting from OOS/OOT, environmental excursions, lab investigations leading to Change Controls for QMS.
In this role you will: - Draft validation documents including validation plans, user requirements specification (URS), risk assessments, configuration specification documents, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocols, trace matrix and summary reports.
- Execute test scripts from IQ/OQ/PQ protocols using good documentation practices and provide appropriate supporting evidence.
- Create and manage project timelines and deliverables.
- Monitor and review Quality Management Systems (CAPA, Change Controls, Deviations) to ensure and maintain compliance with corporate and regulatory agency requirements.
- Contribute to the writing, coordination, review, and approval of Quality Events when needed.
- Coordinate, support, and investigate Corrective and Preventive Actions (CAPAs).
- Draft SOPs and work instructions for asset operation, maintenance, and cleaning.
- Assist in Change Control process from initiation, revision of documents and processes up to training and implementation.
- Assist in preparing QMS training materials and perform training as required.
- Support cross-functional groups for QMS functions and projects not limited to Asset Validation, Equipment Maintenance, Manufacturing, Quality Control, New Hire Onboarding, external and internal audits as needed.
What do we offer? At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics
Comprehensive Benefits:
- Competitive rates for Health, Dental, and Vision Insurance
- 4 weeks of vacation, granted up front each year and prorated for first and last year of employment.
- 12 company paid holidays
- 7 days of sick time
- 100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars
- 100% employer-paid short- and long-Term disability coverage
- 401(k) with immediate eligibility and company match. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
- Partially paid parental leave for eligible employees.
- Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.
