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Cgmp Facilities

4 months ago

Houston, United States Cell Ready, LLC Full time

**cGMP Facilities & Engineering Lead**
- First Shift, Mon-Fri
- $70,000-$125,000 annual compensation
- Excellent Benefits Package
- Must be willing to follow FDA, CDC, EPA and OSHA guidelines.

**Position Summary**:

- You will monitor and maintain a cGMP state-of-the-art manufacturing facility and its support systems.
- The facility has multiple air handlers, chillers, external power generators and G-Con pods.
- Occasionally, work in a clean room environment with a friendly team to provide support and maintenance as needed.

**Responsibilities**:

- Monitor the electrical and mechanical operations and maintenance of the manufacturing facility.
- Monitor cleanrooms and adjacent areas automation systems.
- Monitor, export and trend GMP facility environmental data such as temperature, humidity and pressure differential.
- Assist in investigation of EM excursions.
- Troubleshoot failing facility equipment.
- Perform small electrical and mechanical repairs.
- Help and support facility staff, manages contractors and vendor’s expected services.
- Help facilities and related services for all classified and non-classified manufacturing areas.
- Responsible for facility inspection for quality and operations assurance on a periodic basis.
- Guide and assist project teams in facility expansion, development and maintenance.
- Coordinate facility maintenance activities with senior management staff.
- Comply with requirements of company safety program including health, safety and OSHA requirements.
- Complete any other responsibilities assigned by senior management.
- Ability to work on weekends or in rotating shifts if needed.

**Qualifications**:

- H.S. diploma or equivalent plus 5+ years of related work experience or equivalent combination preferably in an FDA regulated environment
- Must be willing to follow FDA, CDC, EPA and OSHA guidelines
- Strong manual dexterity
- Can easily work with little supervision
- Can lead a shift on occasion with confidence and competence
- Strong attention to detail
- Strong work ethic
- High level of concentration and takes satisfaction in performing tasks with a high level of accuracy
- Good manual dexterity and mechanical aptitude
- Can easily read and interpret work instructions with a high level of accuracy
- Can easily fill out forms accurately and clearly.
- Identify mistakes and defects in workmanship
- Can easily anticipate problems before they occur
- Understands basic line clearance and its rationale
- Ability to communicate with all levels of staff clearly and do so professionally
- Can easily use tools and equipment
- Enjoy continually improving your skills
- Basic computer skills
- Must be able to read, write and understand English
- Must be able to occasionally lift up to 60 pounds.

**Personal Attributes**:

- Team player
- Do the right thing, even when no one is looking
- Great listener
- Accuracy is important
- Attention-to-detail
- Reliable
- Multitasker
- Critical thinking
- Strong team and interpersonal communication
- Quality focus
- Can work at a fast pace
- Even tempered
- Well organized
- Enjoys learning
- Conscientious
- Always conduct yourself with a high level of professionalism in our quest to save lives

**Company Information**

Cell Ready is a privately held contract development and manufacturing organization in Houston Texas, which makes cell and gene therapy drug products that provide incredible results for cancer patients.

With each drug product that we create, we provide cancer patients with a potential cure.

Due to the high market response to our groundbreaking approach to cell and gene therapy manufacturing, CellReady is expanding to a 70,000 sq. ft. facility and is increasing the size and competencies of its staff.

**Reasons to Apply**:

- You will be an instrumental part of a team that will play a critical role in providing society with widespread access to Cell and Gene Therapies, which many believe is one of the most important advances in the history of cancer treatment.
- Cell Ready is a well-funded company with no debt.
- This combination of meaningful work and exceptional compensation is a rare opportunity.

Pay: $70,000.00 - $125,000.00 per year

**Benefits**:

- 401(k) matching
- Flexible spending account
- Health savings account
- Retirement plan
- Tuition reimbursement

Schedule:

- Day shift

Application Question(s):

- Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?

Work Location: In person