Senior QA Validation Specialist

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 You'll 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).
• Facilitate cross-functional teamwork with workstream's stakeholders including harmonization and alignment of own QA Validation deliverables with U.S. QA Validation Management, Global Quality Operations and cross-functional Leadership.
• QA review representative for pre- and post-execution deliverables of validation related documents which may focus on company's assets such as computerized systems, production process equipment, laboratory method studies, facilities and IT infrastructure in scope for GxP matters.
• Review Procedures such as Operational, Maintenance Cleaning documents (OMC) with focus on quality requirements and good documentation practices.
• Review deliverables from Quality Management Systems under VLMS, Change Control and Audits.
• Supports Project Management with Quality focus, Data Management, Digitalization initiatives, Business Continuity and Archival Business Processes.

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.
• Advanced understanding of CQV and Lifecycle Pillars, which may include equipment/asset lifecycle management, equipment qualification execution, equipment operation, equipment maintenance, workflows incl. GxP Computerized System Validation (CSV), Qualification phases such as IQ, OQ, PQ, process validation, method validation and facility's commissioning & qualification.
• Intermediate to Advanced regulatory and auditing understanding.
• Intermediate to Advanced regulatory filing understanding with U.S. FDA such as Biologics License Application (BLA).
• Intermediate to Advanced project management or peer coaching/training experience showing organizational and interpersonal skills.
• Experience with cell-based production processes, cell-based and molecular-based analytical testing in the field of Cell and Gene Therapy including cell production, cell handling & maintenance, cell quantification, viral vector and nucleic acid quantitation or detection (e.g. based on Real Time PCR system).

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.

Competencies:

• 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.

Work Environment:

• 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.

Travel required:

• 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).

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.