Working @ Immatics

Equipment Validation Manager

Permanent employee, Full-time · Houston (TX)

Overview
We are currently seeking a Full Time EQUIPMENT VALIDATION MANAGER for our OPERATIONS DEPARTMENT to support our team. This position will work in Houston, Texas and will be under the supervision of the Sr. Director Technical Operations, is responsible for the planning, scheduling, installation coordination, and qualification of lab and cleanroom equipment of the facility including biological labs, cleanrooms for manufacturing and equipment lifecycle management. The position will represent and work within Operations and cross functionally with various Immatics teams including manufacturing, quality management, process development, Immunology, Biomarkers, Quality Control and Quality Assurance, Procurement, and Project Management on aspects related to equipment lifecycle management and preparing QA/QC and CMC-GMP departments for early to late-stage clinical trials and commercial readiness. The position will be responsible for working with external partners and vendors for the procurement of equipment, qualification services for process equipment in both GLP and GMP Settings
Your mission
The main responsibilities of this position will include but are not limited to the following tasks:
Essential functions: 
  • Day to day activities of Equipment Operations (planning, scheduling, calibration, preventative management, etc.)  
  • Assist with a launch of a new facility, which will include new GLP and GMP equipment and oversee the relocation of existing GLP and GMP equipment to a new facility.  
  • Perform change control assessments for existing QC and CMC-GMP equipment to ensure compliance with regulatory requirements in a phase appropriate manner.  
  • Supervise equipment technicians for in-house preventative maintenance and calibrations. Oversee equipment vendors when outside vendors are selected. 
  • Manage and track all equipment status in an Equipment Management System.  
  • Identify efficiencies and process improvements in the CSV program approach. Works to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment calibration and maintenance, and computer systems validation.  
  • Develop URSs for new equipment, SOPs for equipment maintenance, cleaning and calibration for each piece of equipment 
  • Maintain equipment IDs for each piece of equipment. 
  • Schedule preventative maintenance, respond to urgent maintenance calls and participate in the creation of emergency preparedness plans. 
  • Meet with other team members in order to plan and schedule calibration and maintenance activities for facilities equipment across various facilities. 
  • Work directly with manufacturing, validation, quality assurance/control and other necessary departments to support individual departmental needs. 
  • Assist with forecasts and communication to end users to effectively schedule required maintenance activities while minimizing equipment downtime.  
  • Apply technical and maintenance experience to identify the scope and plan for maintenance activities given available resources, criticality of work and time. 
  • Assist with coordination of activities and schedules related to the use of service vendors. 
  • Coordinate and notify Quality Assurance, Quality Control, and respective teams of any deviations in required conditions inside the facility.  
  • Uses experience and knowledge to solve problems, make decisions and develop plans for the group. 
  • Provide input to Engineering for a Facility and Temperature Storage Units Continuous/Enivronmental Monitoring System. Oversee CMS installation in a new facility and administer the CMS system once qualified.  
 
Secondary functions: 
  • Develop quotes for submission of purchase requisitions for goods and services related to equipment and maintenance activities and budgetary tracking for items. 
  • Assist in the investigation of instrument and equipment related deviations as well as supporting regulatory site inspections. 
  • Assist in planning of future building space, equipment and supply needs. 
  • Coordinate across contractors performing construction in facilities and remodels when necessary. 
  • Assist with Building Management System (BMS) for Facilities.  
  • Assist and coordinate validation efforts inside the cGMP Manufacturing Suites and QC Labs.  
  • Perform risk assessments of equipment events relating to performance for equipment in manufacturing and QC Settings. 
  • Assist with facility repairs in emergency conditions to bring facilities back on line as quickly as possible.  
  • Other duties and tasks as needed and assigned related to facility equipment. 
Your profile
The qualifications for this position include, but are not limited to the following:
  • Minimum of 3 years’ relevant experience in biopharmaceutical manufacturing. 
  • Proven background in developing validation strategies for product manufacturing in the cell and gene therapy industry is preferred.  
  • Working knowledge in biopharmaceutical based GMP equipment and validations operations including experience in support of equipment validation 
  • Thorough knowledge of equipment lifecycle management, calibration, maintenance, cleaning, and validation (IQOQPQ) generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities.  
  • Expertise and working knowledge of cGMP guidelines and knowledge of Quality Systems that meets global regulatory expectations, including knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11 and GAMP 5 requirements, among others.  
  • Demonstrated ability to author, review and implement policies or procedures for compliance with regulatory guidance.  
  • Understanding of industry trends and leading methodologies. 
  • Proficient in the use of spreadsheets, databases and word processing software. 
  • Excellent Communications and interpersonal skills. 
  
Work environment: 
Office, Labs, and Cleanroom Environments 
 
Physical demands: 
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: 
  • Experience prolonged sitting, standing, walking, bending, stooping, and stretching. 
  • Use hand-eye coordination and manual dexterity sufficient to operate portable tools, as well as a computer keyboard, telephone, calculator, and other office equipment is required. 
  • Have a normal range of vision. 
  • May be required to lift up to 50 pounds on occasion. 
  • Climb ladders and stairs of various heights. 
  • Be exposed to wet or humid conditions. 
  • This position may include On-Call response for Facility issues. 
  • Be exposed to outdoor weather conditions. 
  • Be exposed to noisy environments. 
  • Attendance is mandatory 
 
Travel required:  
  • Local travel may be required between facilities until all are combined. 
 
Required education and experience 
  • Associates degree in a related discipline with a minimum of 5 years of overall experience on which at least 1-year must be in a cGMP or other FDA regulated operation; OR 
 
Preferred education and experience 
  • Bachelor's degree in a related discipline with a minimum of 3 years of overall experience on which at least 1-year must be in a cGMP or other FDA regulated operation;  
  • GMP working knowledge 
  • Quality Systems  
 
Additional eligibility requirements: 
  • NA 
 
Work authorization/security clearance requirements 
Authorization to work in the United States.  
 
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.” 
 
Other duties  
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 
 
 
We expect a high degree of independent working, analytical reasoning and excellent communication skills. You embrace rapidly changing requirements with an open mind, think outside the box and show a high degree of flexibility in an environment which is marked by a constant striving for excellence. You approach tasks in a structured, 
reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills. 
Why us?
What Immatics Offers
We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills. Immatics offers partial subsidized health, dental and vision 
insurance, 401(k), 160 hours of PTO annually, paid holidays, paid parking, paid short/long term disability/AD&D and life insurance. 
Notice
NOTICERecruitment is managed through Immatics US’ Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Immatics US, and no fee/payment will be paid. Recruiters interested in working with Immatics US can submit their information to HR-US@immatics.com, and we will contact you if needed.  
 
Immatics values diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
About Us
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets.

This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.