Validation Engineer

Department:   R&D and Validation 

The Validation Engineer is responsible for the regulation and support of equipment and systems. Assists in equipment selection, specification, and negotiating fees. Maintains all records related to qualification and validation. Works on projects where data analysis requires evaluation of defined factors to broad concepts. Utilizes independent judgment within broad parameters to determine an appropriate solution.  Prepares validation reports, suggests and assists in determining specifications, and makes recommendations for modifications as necessary.  The Validation Engineer reports to the Validation Supervisor.

Education/Experience:

• B.S. in science/engineering field and 1 to 2 years of equipment qualification/validation experience 

Skills/Abilities:

• Ability to understand and demonstrate knowledge of Standard Operating Procedures (SOPs).
• Demonstrates knowledge of Good Manufacturing Practice (GMP) and FDA 21 CFR 210/211/820, EU GMP Annex 1, ICH guidelines.
• Hands-on experience with Kaye validator and temperature mapping.
• Soft skills such as technical writing, good communication skills, root-cause investigation and cross-functional coordination skills, detail-oriented mindset.

Responsibilities include, but are not limited to:

• Author I/O/PQ protocols, periodic review documents, specifications, SOPs and summary reports.
• Maintain and execute equipment periodic review activities for various 

departments equipment and systems including Facilities, Environmental Monitoring, Bioassay, Manufacturing and Quality Control. 

• Co-ordinate with various departments and stakeholders to gather information and documentation related to the equipment and systems. 
• Assist in specifying and selecting equipment.  Maintains all records related to qualification and validation.  
• Prepare periodic review and validation summary reports and make recommendations for modifications as necessary.
• Initiate and maintain Deviation and CAPA activities and perform any corrective actions as needed. 

WORK HOURS:

Position is full time. 

This position may require periodic local travel between CEL-SCI Facilities, to contract facilities, and to external Validation providers.  

LOCATION:

Baltimore & Elkridge, MD

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.  

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email  

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

Analytical Research Associate 

Department:   R&D and Validation 

Analytical Research Associate participates in various research, development, and validation activities for new and existing analytical methods. Duties may include evaluation of new and existing methods, development of new and existing methods, and validation of new or updated methods. The Analytical Research Associate reports to the R&D Manager and/or the Senior Director of R&D and Validation.

Education and Experience:

• B.S. and 2 years’ experience (or equivalent experience in related field)
• Experience in research or clinical laboratory 
• Experience in assay development / troubleshooting, bioassays, cell culture, ELISA, PCR, and other analytical methods preferable

Skills/Abilities:

• Demonstrates knowledge of Standard Operating Procedures (SOP)
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment
• Performance of various analytical methods
• Strong data analysis 
• Strong organizational skills and attention to detail, with the ability to multitask and switch tasks effectively
• Strong technical writer  

Responsibilities include, but are not limited to::

• Responsible for executing research and development activities under direct supervision
• Responsible for executing validation activities in support of QC under direct supervision

• Perform analytical methods experiments
• Collects data and prepares preliminary reports
• Maintains files for R&D and validation documentation
• Assist in laboratory and equipment maintenance activities
• Draft/revise R&D and GMP documentation including SOPs, Forms, and Reports 

Work Hours:  

Position is full time, on site.  Monday through Friday - 8:00–5:00 (with 1 hour lunch) or 8:30–5:00 (with 30-minute lunch).  Occasional early and late work may be required.

Location: 

North Baltimore, MD.

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.   

Please submit cv/resume to careers@cel-sci.com.  Reference the job title in the subject line of the email  

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

Manufacturing Support Technician

Department:  Manufacturing

The Support Technician contributes to the manufacturing team effort by accomplishing related tasks and assignments.  The Manufacturing Support Technician reports directly to Supervisor of Manufacturing. 

Education and Experience:

• High School Diploma and 1+ year’s relevant experience, or
• High School Diploma and certification through accredited biotechnology instruction relevant experience.
• AA Degree in a related field 
• BS/BA Degree in a related field

Skills/Abilities:

1. Understanding and awareness of current Good Manufacturing Practices. (cGMP) and basic familiarity with FDA and EU Guidelines.
2. Able to follow Standard Operating Procedures (SOP’s).
3. Work in a classified environment.

Responsibilities include, but are not limited to:

1. Use of the autoclave, depyrogenation oven and sonicator.
2. Clean Formulation and Fill Vessels.
3. Gowning for classified areas.
4. Stock and stage processing areas.
5. Other duties as assigned.

WORK HOURS:

Position is full time. Weekend, holiday, and evening work to be assigned on a rotating basis, as needed.

Limited local travel to other Company facilities may be required.

LOCATION:

Elkridge, MD

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.   

Please submit cv/resume to careers@cel-sci.com.  Reference the job title in the subject line of the email  

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

IT Specialist - GMP Systems

Department:  Operations

The IT Specialist - GMP Systems is responsible for supporting a broad range of needs related to CEL-SCI’s GMP IT infrastructure and the use of electronic devices (i.e., desktop computers, laptop computers, network servers, tablets) that support the manufacturing and testing of our cancer immunotherapy, Multikine, as well as working with the Company’s IT consultant. Digital information assessed by, created by, and stored by CEL-SCI is highly confidential and must be protected from all outside parties.  As a biopharmaceutical company making a complex biological drug, the IT Specialist will ensure that CEL-SCI follows Current Good Manufacturing Practices (cGMP) as outlined in the US Code of Federal Regulations (CFR) Title 21 Parts 210 and 211, Part 11 and European Union (EU) Annex 11.0.  The IT Specialist reports to the Operations Department with its primary role to support the validation department during the GMP computer systems validation efforts.

Requirements:

Education & Experience:

• Bachelor’s degree or equivalent college level training, Computer Science degree preferred
• 5+ years’ experience in a pharmaceutical/biopharmaceutical environment
• Knowledge of FDA Title 21, Parts 210 and 211 cGMP (Current Good Manufacturing Practices), Part 11 (Electronic Records/Electronic Signatures) and EU Annex 11 (Computerized Systems)

Skills & Abilities:

• Strong understanding of Computer System GMP regulatory requirements (21 CFR Part 11, Annex 11)
• Strong technical writing and editing skills to draft IT Program Documents that support GMPs
• Capability to suggest and implement working solutions that meet cGMP computer system compliance
• Ability to administer multiple systems simultaneously
• Comfortability to work in a team environment to meet project deadlines
• Excellent communication skills
• Strong organizational skills
• Strong inventory tracking skills

Technical Competencies:

• Strong knowledge and abilities in Microsoft Office Applications
• Strong knowledge of Windows OS
• Strong Knowledge of Windows Server 2016 and newer
• Work experience setting up new Windows server from start to finish
• Strong knowledge of Active Directory, DHCP, DNS, Group Policy
• Strong knowledge of router/firewall configuration and maintenance
• Work experience with Cisco, Sonic Wall, and/or Ubiquiti router/firewall is a plus
• Strong knowledge of TCP/IP protocol
• Entry level knowledge of cloud solutions like Microsoft Azure
• Entry level knowledge of various computer programming languages 
• Knowledge of SQL Server and SQL programing is a plus

Responsibilities include, but are not limited to:

• Develop IT policies, Standard Operating Procedures (SOPs), and data storage requirements that fit within the overall GxP strategy and support quality standards to ensure compliance with regulatory guidelines
• Initiate, assess, implement, and approve change controls as they relate to IT and GMP computer systems
• Provide IT technical review for Standard Operating Procedures (SOPs), Computer Systems Validation (CSV) protocols, equipment specifications, etc., as appropriate
• Implement system securities and user access management restrictions to ensure data integrity
• Perform Data Integrity assessments and remediations for GMP computer systems periodically
• Develop a robust back-up and restoration program for GMP-relevant systems that reside at multiple locations
• Collaborate within a team environment to ensure appropriate documentation of IT responsibilities throughout the CSV process
• Assist in the maintenance of a computer system inventory in accordance with the Computer System Validation Master Plan (VMP)
• Troubleshoot issues with computer systems during GMP manufacturing activities
• Train employees on IT procedures applicable to the GMP manufacture and testing
• Support the IT consultant in building  or repair network hardware and infrastructure
• Recommend IT purchases as needed
• Provide help desk services to employees
• Administer GMP computer systems to ensure alignment with GMP policies and procedures
• Assist the IT consultant with  local workstation permission settings, periodic review and back-up
• Other duties as assigned

Other:

• Ability to stand, walk, and sit for hours
• Ability to work in tight environments with little room for maneuvering
• Ability to lift up to 50 LBS

Work Hours:

Position is full time. Monday through Friday.  Occasional evening and weekend work may be required.  Travel to the R&D laboratory facility in Baltimore, MD (20 minutes north) will be required.  Must be able to work non-standard hours (weekends, evenings, nights) as needed.

Location:

Elkridge, MD

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options. 

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email 

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.