Department: Azzur Cleanrooms On Demand San Diego LLC
Summary Objective of position:
The Operations Engineer is responsible for providing Engineering support to the installation, commissioning, validation, operation and maintenance of the equipment and facilities at Azzur Cleanrooms On Demand (COD) as a full time employee (40 hrs per week on average).
(total Should equal 100% of essential functions, not 100% of total job)
Provide Engineering and Facility support to the Operations Team including:
1. Provide engineering support to existing and/or new equipment and facility assets throughout their life cycle. Typical activities include:
a. Equipment validation/qualification including generation and execution of IQ,OQ,PQ Protocols
b. Equipment maintenance
c. Equipment calibration
d. User Requirements Specifications
e. Change Controls
2. Collect, analyze and report data
3. Support and/or manage capital projects
4. Create and/or revise Standard Operating Procedures (SOPs)
5. Participate in, support and/or lead Quality Investigations, Root Cause Analysis and CAPA Implementation
6. Participate in, support and/or lead Risk Assessments including FMEAs
7. Assist with materials management activities including shipping, receiving and material restocking
8. Assist with various facility activities including site and asset maintenance
9. Assist with scheduling, operations management and enforcement of facility regulations
Additional Functions: (list additional tasks that may be occasionally required)
1. Support engineering activities at Waltham COD site on a limited basis
2. Other duties as assigned
· Handling multiple responsibilities and job tasks (multi-tasking) as needed.
· Demonstrating attention to detail.
· Flexibility with work requirements, work environment and fast-paced/changing job needs.
Promoting teamwork by:
· Collaborating with co-workers.
· Leading team meetings as required.
· Meeting individual company goals as established.
· Establishing rapport and maintaining positive communication with others,
· Demonstrating respect, support, cooperation and flexibility with changes in schedule or priority.
· Adhering to company and department policies.
Maintains technical knowledge by attending educational workshops and/or reviewing publications.
Adhere to all Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP).
Training & Development:
Ensure training has been received before undertaking specific duties and that all training is documented in training records.
Health & Safety:
Understand the company’s Health & Safety Policy and follow all associated procedures. Report all accidents or awareness of any unsafe conditions in the workplace to management.
Human Resource Management:
Conform to the company’s policies contained in the Employee Handbook
Basic Qualifications & Position Requirements: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.)
· Bachelor’s Degree
· Bachelor’s Degree with a study concentration in a scientific discipline
Required Work Experience:
· 1 yr experience as a technical contributor and/or in project management
· 3 yrs experience as a technical contributor and/or in project management
· Experience with capital projects and budget management, financing and related activities
· Experience with facility, utilities, equipment and system (FUSE) qualification
· Experience working in cGMP environment of Pharmaceutical or Medical Device industry
· Facilities, Utilities, Equipment and Manufacturing systems
· Microsoft Word, Excel, Powerpoint
Skills (incl.Typical Mental Demands):
Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:
· Computer skills, basic engineering and mathematical skills, use of spreadsheets
· Communication proficiency
· Attention to detail
· Can work productively independently with minor supervision
· Self-motivated, flexible, dependable and available
· Excellent organizational and time management skills
Work Environment & Dress attire: (The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.)
Business Casual attire is required.
Physical Demands (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.)
Number of Hours/Day
Number of Hours/Day
Number of Hours/Day
(List Frequency; hrs./day)
Equipment To Be Used:
Travel (frequency and/or percentage)
Minimal travel expected