Validation Engineer II

Title: Validation Engineer II

Location: Houston

Job Description:

Join Immatics and shape the future of cancer immunotherapy; one patient at a time! 

Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment.

Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies.We usethesepowerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology.

 

Why Join Us?

• Innovative Environment:Help topioneeradvancements in cancer immunotherapy.

• Collaborative Culture:Be part ofa diverse team dedicated to your professional growth.

• Global Impact: Contribute to therapies that make a lasting impact on patientsglobally.

 

We are seeking aValidation Engineer IIto support our CSV Engineering Team. The Validation Engineer II will help lead the implementation of new systems through the validation process and ensure all validation deliverables and regulations have been met.

 

FLSA Classification: Salary, Exempt
Schedule: 8:00 AM – 5:00 PM; Monday to Friday; On-site
Reports to: Validation Manager
Location: 13203 Murphy Road Suite 100 Stafford, TX 77477

 

What You’ll Do:

As aValidation Engineer II, you will play a key role in supporting our CSV Engineering Team:

• 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) and Batch Record Issuance procedures 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 system 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 .

• Support cross-functional groups for QMS functions and projects not limited to Computer Systems Validation, Equipment Maintenance, Manufacturing, Quality Control, New Hire Onboarding, external and internal audits as needed.

 

Required Experience and Education:

• Bachelor’s Degree in Science, Engineering or a related major. Education in Biotechnology or a related major preferred

• A minimum of 0-3 years of experience working in the pharmaceutical industry within a fast-paced environment with minimum supervision.

 

Preferred Experience and Education:

• A minimum of 0-3 years of experience working in the Biotechnology industry within a fast-paced environment with minimum supervision.

 

Competencies:

• Experience working within a GxP regulated manufacturing or laboratory environment.

• An understanding of good documentation practices and data integrity principles.

• An understanding of 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, GAMP 5 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.

• Ability to make sound decisions and approach problems with curiosity and open-mindedness.

• High degree of independent working, analytical reasoning, and the ability to communicate effectively.

 

Work Environment:

This is a sedentary position (at least 50% of time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is . Occasional lifting of objects up to 25 lbs is expected.

 

Travel required: This is a hybrid on-site position with less than 5% travel expected.

 

Physical demands:

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.

• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.

• Keyboarding– entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.

• Lifting-raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.

• Near Visual Acuity– clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).

• Pushing- Exerting force upon an object so that the object moves away from the object.

• Pulling- Exerting force upon an object so that the object moves toward the force.

• Sitting– remaining in a sitting position for at least 50% of the time.

• Standing/Walking-remain on one's feet in an upright position at a workstation.

• Stooping–occasional bendingthe body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.

 

Work authorization/security clearance requirements:

 

Legal eligibility to work in the United States is . Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.

 

Affirmative Action/EEO statement:

 

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs.We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

 

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 Paid Time off, granted up front each year and prorated for first and last year of employment.

• Sick Time Off – 56 hours

• 12 Paid Holidays

• 100% Employer-Paid Life Insurance up to at 1x annual salary

• 100% Employer Paid Short- and Long-Term Disability Coverage

• 401(k) with Immediate Eligibility  & company match…

• You are eligible for 401(k) plan participation as of your first paycheck.

• The company will match 100% of your contributions upto 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 paidParental Leave for eligible employees. (3 weeks)

• Additional voluntary employee paid coveragesincluding  Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance.

 

Professional Growth:

• Opportunities to work with leading experts in the field of T-cell immunotherapy.

• Company provided learning and development opportunities

• Fast paced, high demand collaborative and dynamic environment.