Facilities Engineer | CEL-SCI

The Facilities Engineer works under the direct supervision of the Director of Facilities. The candidate will participate in the management of a safe and efficient constantly evolving work environment essential to the performance of GMP facilities.

The candidate should have the ability to adapt to changes in the work / facility environment and be self-motivated with a strong sense of ownership in areas of responsibility.

Must be on call 24 / 7 to respond to facilities matters, security and Building / Equipment Monitoring Systems alarms (emergency response is assigned on a rotating basis).

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Education :

• Bachelor’s Degree preferably in Engineering such as Mechanical, Electrical, or Biomedical with two (2) years of experience in engineering and maintenance in an FDA cGMP regulated manufacturing facility; OR
• Associate’s Degree preferably in Engineering such as Mechanical, Electrical, 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.

Experience :

Experience in facilities maintenance with at least 2+ years’ in an FDA cGMP regulated facility preferably in the pharmaceutical, biotechnology or biopharmaceutical industry.

Essential Functions :

• Perform a variety of maintenance / minor repair activities on the interior areas of the Facilities.
• Support Engineering projects and provide support to other departments as required.
• Responsible for authoring / revision of Facility Department SOPs.
• Assure supervision of outside contract services ensure tasks are completed in accordance with contract / work orders, and all paperwork is complete.
• Participate in and ensure all work orders are properly documented according to policies, procedures and Good Documentation Practices (GDP).
• Proactively seek ways to increase equipment reliability and operational efficiency.
• Participate in the oversite of contracted maintenance service by providers and contractors while they are on-site performing project work, maintenance, and / or repairs on facility’s structure, systems and equipment.
• Strong Project Management and communication Skills .
• Ensure safe working conditions are maintained in accordance with the Safety Program and directions from the Safety Officer and Facility management.
• Ensure the performance, condition and reliability of all plumbing, mechanical and electrical equipment including emergency equipment, and periodic testing of the same, to assure efficient, consistent and reliable operation.
• Report deviations arising from Building / Equipment Monitoring Systems to the Director of Facilities.
• Participate in an ongoing, periodic and annual assessment of facilities to identify any needed repairs and improvements.
• Support installation, commissioning and validation activities for the Facility and Facilities Equipment.
• Be able to lift 50 lbs., climb a ladder and perform various minor maintenance, as needed.
• Participate on rotation basis on the Facility’s emergency call list (24 / 7), including weekends / holidays.
• 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 managements 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 reports for an FDA cGMP regulated facility.
• Knowledge of FDA, ICH, EU, UK regulations as they apply to facilities for the manufacture of injectable sterile medicinal products, 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, MS-Project, Siemens BAS 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.

Work Hours :

Position is full time, on site.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 is required.

Location :

Baltimore and Elkridge, Maryland Full-Time (On-Site)

Requires travel between CEL-SCI’s Baltimore and Elkridge Maryland facilities locations.

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

Please submit cv / resume and cover letter to [email protected] . 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.

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