Facilities Engineer
CEL-SCI
Posted 2 weeks ago
Facilities Engineer
Department: Facilities
DESCRIPTION:
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.
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.
Apply For This Job
Name*
Email*
Phone*
A valid phone number is required.
Cover Letter*
Attach Resume*
Submit Close