Overview
Automation Engineer Jobs in Novi, MI at iTechstack
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 use these powerful 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 to pioneer advancements in cancer immunotherapy.
Collaborative Culture: Be part of a diverse team dedicated to your professional growth.
Global Impact: Contribute to therapies that make a lasting impact on patients globally.
We are seeking an Operational Quality Assurance Specialist II to join our Operational Quality Assurance team. In this role, the specialist will be responsible for conducting internal audits of manufacturing and CMC (Chemistry, Manufacturing, and Controls) procedures, ensuring compliance with regulatory and company standards. The position also involves tracking and maintaining critical documentation such as standard operating procedures, work instructions, lab notebooks, and manufacturing data. Additionally, the specialist will oversee and execute official batch and material release activities, supporting overall quality assurance operations.
FLSA Classification: Hourly, Non-Exempt
Schedule: 0800 – 1630; Monday to Friday; On-site
Reports to: Senior Manager, Operational Quality Assurance
Location: 13203 Murphy Road Suite 100 Stafford, TX 77477
What You’ll Do:
As an Operational Quality Assurance Specialist II, you will play a key role in supporting our batch and material release:
Maintaining equipment logs and files
Tracking manufacturing numbers
Performing internal audits of the manufacturing process
Writing audit reports
Creating and performing internal Quality Assurance trainings for Immatics personnel
Writing new standard operating procedures and batch records
Keeping track of lab notebooks
Providing support for the investigation and recall of non-conforming materials
Writing, reviewing, and tracking deviation reports, corrective and preventive actions (CAPA) reports, maintenance reports and Out of Specification (OOS) reports
Issuance and reconciliation of final product labels
Certificate of Analysis (CoA) review and release for completed batches
Review of sterility, endotoxin, and mycoplasma results
Reagent review and release
Initiation and completion of Change Controls for all updates to processes or documents
Maintains electronic log of all US equipment
Required Experience and Education:
Bachelor’s Degree in a Life Science Discipline is required.
2-3 years experience in QA, Auditing, or clinical manufacturing in a research environment.
At least 3-5 years of Biotechnology and/or pharmaceutical industry experience is required.
Experience comprehending regulations and guidance documents.
Competencies:
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
Careful editing and documenting of results
Ability to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by a constant striving for excellence
Ability to approach tasks in a structured, reliable, and foresighted manner; combined with a high level of individual responsibility, enthusiasm, and strong social skills
Ability to effectively collaborate with members from other departments
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 required. Occasional lifting of objects up to 25 lbs is 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 bending the 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 required. 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, up to 100K (club together)
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 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. (3 weeks)
Additional voluntary employee paid coverage including 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.
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Title: Automation Engineer
Company: iTechstack
Location: Novi, MI
