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.
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
Required education and experience
- Local travel may be required between facilities until all are combined.
Preferred 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
Additional eligibility requirements: Work authorization/security clearance requirements
- 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
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.