Facilities Engineer

CEL-SCI Corporation; Baltimore (MD); Presencial; USD 85 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salaries

Outstanding benefits

Employee Stock Options

Resumo da oferta

CEL-SCI Corporation in Baltimore, MD seeks a Facilities Engineer to support a GMP manufacturing environment under the Facilities Manager. On-call 24/7 rotation, you will respond to facility alarms and coordinate maintenance, with a focus on reliability and safety.

The role covers SOP authoring, project support, equipment monitoring, and collaboration across departments. Strong problem-solving, documentation, and scheduling skills are essential for daily operations and compliance.

Qualificações

• Bachelor’s or equivalent with relevant GMP experience.
• Engineering background with laboratory/manufacturing facility exposure preferred.
• Fluency in applicable regulations and standard operating procedures.

Responsabilidades

• Support facilities projects and assist other departments.
• Author/revise Facility SOPs.
• Oversee outside contractors per contracts and work orders.
• Document all work per GDP and company policies.
• Improve equipment reliability and operational efficiency.
• Lead or participate in project management activities.
• Perform maintenance and repair inside facilities.
• Maintain safe working conditions as directed by Safety team.
• Monitor plumbing, mechanical and electrical equipment and alarms.
• Support installation, commissioning and validation activities.
• Be able to lift 50 lbs and climb ladders as needed.
• Participate in 24/7 emergency call rotation.

Conhecimentos

SOPs & reports

ICH/FDA/EU regs

Organizational skills

Multi-tasking

Analytical skills

MS Project / Word / Excel

Blue-Mountain / Siemens BAS / REES

CAD knowledge

Facility monitoring systems

Policy compliance

Gowning certification

Formação académica

Bachelor’s Degree in Engineering (Electrical/Chemical/Mechanical/Biomedical)

Associate’s Degree in Engineering

High School Diploma with related training + 6 years experience

Ferramentas

Blue‑Mountain

Siemens BAS

REES

CAD system

Descrição da oferta de emprego

The Facilities Engineer works under the direct supervision of the Facilities Manager. The candidate will contribute to a safe and efficient working environment essential to the performance of a GMP facility. The candidate should have the ability to adapt in a constantly evolving environment and be self-motivated with a strong sense of ownership in areas of responsibility. On-call availability (24/7) to respond to facilities matters, security, and building/equipment monitoring alarms is required on a rotating basis, including weekends/holidays.

Education and Experience

• Bachelor’s Degree preferably in Engineering such as Electrical, Chemical, Mechanical or Biomedical with two (2) years of experience in engineering and maintenance in an FDA cGMP regulated manufacturing facility preferably in the pharmaceutical, biotechnology or biopharmaceutical industry; OR
• Associate’s Degree preferably in Engineering such as Electrical, Chemical, Mechanical or Biomedical with four (4) years of experience in engineering and maintenance in an FDA cGMP regulated research or manufacturing facility; OR
• High School Diploma with at least one year of education or training in a college, university or trade school plus six (6) years of relevant engineering work experience in a bio‑pharma research, manufacturing facility operating under cGMP environment or related industry.

Essential Functions

• Participate in Facilities projects and provide support to other departments as required.
• Responsible for authoring/revision of Facility Department SOPs.
• Assure outside contract services performing project work, maintenance, and/or repairs and projects on buildings, systems and equipment are properly supervised and tasks are completed in accordance with contract/work orders.
• Ensure all work is properly documented according to policies, procedures and Good Documentation Practices (GDP).
• Proactively seek ways to increase equipment reliability and operational efficiency.
• Strong Project Management Skills.
• Perform a variety of maintenance/repair activities on the interior areas of the Facilities.
• Ensures that safe working conditions are maintained in accordance with the Safety Program and directions from the Safety Officer and Facility management.
• Participates in ensuring the performance, condition and reliability of all plumbing, mechanical and electrical equipment including emergency equipment, and periodic testing of the same, to assure they operate efficiently and consistently.
• Responsible for monitoring building/equipment Monitoring Systems
• Participate in an ongoing assessment of the facilities to identify repairs and improvements.
• Supports installation, commissioning and validation activities for the Facility and Facilities Equipment.
• Be able to lift 50 lbs, climb a ladder, as needed.
• Participate on rotation basis on the Facility’s emergency call list (24/7).
• Other tasks as assigned.

The above statements are intended to describe the general nature of work performed by those in this position and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this position at any time which reflects management’s determination for assignment of essential functions.

Skills

• Demonstrated ability to write facilities‑related SOPs and technical reports.
• Knowledge of ICH guidelines and FDA and EU regulations as they apply to facilities, a plus.
• Excellent organization and communication skills.
• Must have the ability to multi‑task and coordinate workload by priority.
• Strong analytical skills, particularly with respect to identifying and implementing technical solutions to process, utility and facility equipment / systems.
• Proficiency in Microsoft Project, Word and Excel, and working knowledge of and experience with the following systems: Blue‑Mountain, Siemens BAS, and REES are desired. Knowledge of CAD‑system a plus.
• Other computer skills and knowledge of various Facility and Facility equipment monitoring systems a plus.
• Must comply with all applicable policies, rules and regulations of CEL‑SCI and the Pharmaceutical/Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations and Company regulations such as the employee handbook and safety manual.
• The ideal candidate will be expected to take part in gowning certification for clean room activities.

Work Hours

• Monday through Friday – 7:30 a.m.-4:00 p.m. with 30‑minute lunch or 8am-5pm with 1hr lunch (hours may vary on occasion). After hours response to emergency required. Ability to work flexible schedule, if required.

Location

• Baltimore and Elkridge, MD.
• Requires travel between CEL‑SCI’s Baltimore and Elkridge Maryland facilities locations.

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

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.