Immatics
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Senior QA Validation Specialist
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Immatics 1 day ago Be among the first 25 applicants Join to apply for the
Senior QA Validation Specialist
role at
Immatics Direct message the job poster from Immatics Senior Talent Acquisition Specialist Immatics US, Inc.
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 a
Senior Quality Assurance Validation Specialist
to support our Quality Assurance Validation team. The Senior Quality Assurance Validation Specialist will be a Subject Matter Expert in quality matters in the biopharmaceutical industry: this role serves as on-site QA representative in the U.S. based QA Validation team to handle commissioning, qualification and validation (CQV) activities. Specialist support covers multiple aspects in the Validation Lifecycle Management System (VLMS) from clinical phase toward commercialization including but not limited to quality oversight in equipment validation, analytical method validation and manufacturing process validation. FLSA Classification : Salary/ Exempt Schedule : 8:00 AM 5:00 PM; Monday to Friday; On-site (Overtime hours on a business need basis) Reports to : Manager, QA Validation Location : 13203 Murphy Road Suite 100 Stafford, TX 77477 What Youll Do: As a
Senior Quality Assurance Validation Specialist,
you will play a key role in supporting our validation operations: QA Review of validation documents including User Requirement Specifications, Design Verifications, Risk Assessments, Validation Plans, Qualification Protocols, Validation Reports. Quickly recognize, implement, and enforce compliance with applicable regulations, Propose best practices based on industry standards & guidance as well as state-of-the-art in the field of Cell Therapy (e.g. Adoptive Cell Therapy). (Additional information on Immatics Job Posting) Secondary Functions: Secondary functions, ad-hoc or in case of need as directed by line manager, QA Validation: Support the Operational Quality Assurance Systems organization. Support Quality initiatives. Support Operational Excellence and Lean concepts Required Experience and Education: At least 4 + years' experience in a related role Batchelor's degree in Computer Science, Life Sciences, or Engineering Able to work on-site: work includes traveling between different local collaborating U.S. sites and able to work in different working environments incl. office space, controlled rooms (laboratory, production facility). Shows can-do attitude, analytical and effective problem-solving skills (e.g. root cause analysis), attention to detail, high level of accuracy, flexible reasoning, ability to prioritize, critical thinker, high performing individual under tight timelines. Shows strong verbal and written communication and excellent technical writing including proficient use of Microsoft Excel, Word, and Power Point. Possess scientific, technical background with experience in Biotechnology, Engineering, Computer Science or related field as well as work experience in related Biopharma industry or similar regulated settings. (Additional information on Immatics Job Posting) Preferred Experience and Education: Experience in a wide variety of documents creation/contribution supporting qualification, validation, and release of pieces of equipment for quality control, or production (clinical and/or GMP commercial) within biopharma regulated settings. Experience in audit and inspections within regulated settings. Experience in Quality Assurance Release responsibilities within regulated settings. Experienced in Software application deployments and administration. Experience in analytical method validation. Experience in manufacturing process validation. Experience with IT infrastructure, computer/digital systems, and software solution deployments for biopharmaceutical business operations. Contributed to manufacturing site deployment activities in the biopharmaceutical industry. Experience in project management for operational excellence and lean concepts in the regulated pharmaceutical industry. Shows can-do attitude, analytical and effective problem-solving skills (e.g. root cause analysis), attention to detail, high level of accuracy, flexible reasoning, ability to prioritize, critical thinker, high performing individual under tight timelines. Shows strong verbal and written communication and excellent technical writing including proficient use of Microsoft Excel, Word, and Power Point. This position works in a typical office and/or lab and/or manufacturing clean room environment and/or other supporting facility areas with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. Able to work on-site: work includes traveling between different local collaborating U.S. sites and able to work in different working environments incl. office space, controlled rooms (laboratory, production facility). 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 teams health, safety and well-being. Heres what you can expect if you join Immatics 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 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. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Quality Assurance, Manufacturing, and Other Referrals increase your chances of interviewing at Immatics by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Paid maternity leave Paid paternity leave Get notified about new Quality Assurance Specialist jobs in
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Senior QA Validation Specialist
role at
Immatics 1 day ago Be among the first 25 applicants Join to apply for the
Senior QA Validation Specialist
role at
Immatics Direct message the job poster from Immatics Senior Talent Acquisition Specialist Immatics US, Inc.
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 a
Senior Quality Assurance Validation Specialist
to support our Quality Assurance Validation team. The Senior Quality Assurance Validation Specialist will be a Subject Matter Expert in quality matters in the biopharmaceutical industry: this role serves as on-site QA representative in the U.S. based QA Validation team to handle commissioning, qualification and validation (CQV) activities. Specialist support covers multiple aspects in the Validation Lifecycle Management System (VLMS) from clinical phase toward commercialization including but not limited to quality oversight in equipment validation, analytical method validation and manufacturing process validation. FLSA Classification : Salary/ Exempt Schedule : 8:00 AM 5:00 PM; Monday to Friday; On-site (Overtime hours on a business need basis) Reports to : Manager, QA Validation Location : 13203 Murphy Road Suite 100 Stafford, TX 77477 What Youll Do: As a
Senior Quality Assurance Validation Specialist,
you will play a key role in supporting our validation operations: QA Review of validation documents including User Requirement Specifications, Design Verifications, Risk Assessments, Validation Plans, Qualification Protocols, Validation Reports. Quickly recognize, implement, and enforce compliance with applicable regulations, Propose best practices based on industry standards & guidance as well as state-of-the-art in the field of Cell Therapy (e.g. Adoptive Cell Therapy). (Additional information on Immatics Job Posting) Secondary Functions: Secondary functions, ad-hoc or in case of need as directed by line manager, QA Validation: Support the Operational Quality Assurance Systems organization. Support Quality initiatives. Support Operational Excellence and Lean concepts Required Experience and Education: At least 4 + years' experience in a related role Batchelor's degree in Computer Science, Life Sciences, or Engineering Able to work on-site: work includes traveling between different local collaborating U.S. sites and able to work in different working environments incl. office space, controlled rooms (laboratory, production facility). Shows can-do attitude, analytical and effective problem-solving skills (e.g. root cause analysis), attention to detail, high level of accuracy, flexible reasoning, ability to prioritize, critical thinker, high performing individual under tight timelines. Shows strong verbal and written communication and excellent technical writing including proficient use of Microsoft Excel, Word, and Power Point. Possess scientific, technical background with experience in Biotechnology, Engineering, Computer Science or related field as well as work experience in related Biopharma industry or similar regulated settings. (Additional information on Immatics Job Posting) Preferred Experience and Education: Experience in a wide variety of documents creation/contribution supporting qualification, validation, and release of pieces of equipment for quality control, or production (clinical and/or GMP commercial) within biopharma regulated settings. Experience in audit and inspections within regulated settings. Experience in Quality Assurance Release responsibilities within regulated settings. Experienced in Software application deployments and administration. Experience in analytical method validation. Experience in manufacturing process validation. Experience with IT infrastructure, computer/digital systems, and software solution deployments for biopharmaceutical business operations. Contributed to manufacturing site deployment activities in the biopharmaceutical industry. Experience in project management for operational excellence and lean concepts in the regulated pharmaceutical industry. Shows can-do attitude, analytical and effective problem-solving skills (e.g. root cause analysis), attention to detail, high level of accuracy, flexible reasoning, ability to prioritize, critical thinker, high performing individual under tight timelines. Shows strong verbal and written communication and excellent technical writing including proficient use of Microsoft Excel, Word, and Power Point. This position works in a typical office and/or lab and/or manufacturing clean room environment and/or other supporting facility areas with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. Able to work on-site: work includes traveling between different local collaborating U.S. sites and able to work in different working environments incl. office space, controlled rooms (laboratory, production facility). 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 teams health, safety and well-being. Heres what you can expect if you join Immatics 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 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. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Quality Assurance, Manufacturing, and Other Referrals increase your chances of interviewing at Immatics by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Paid maternity leave Paid paternity leave Get notified about new Quality Assurance Specialist jobs in
Stafford, TX . Quality Assurance Specialist (Chemicals)
Houston, TX $102,203.00-$132,870.00 6 days ago Material Handling & Quality Assurance Specialist
Material Handling & Quality Assurance Specialist
Call Center Quality Assurance Specialist
Automotive Photo Quality Assurance Associate 48904
Houston, TX $67,500.00-$96,400.00 1 week ago Quality Assurance/Quality Control Manager (Infrastructure Projects)
Quality Assurance Quality Control Analyst
Pearland, TX $60,000.00-$70,000.00 1 week ago Quality Assurance / Quality Control Manager (Infrastructure Civil Engineer)
Houston, TX $115,400.00-$157,200.00 20 minutes ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr