Tunnell Consulting Inc. Sr. Engineer - Facilities in Lafayette, Indiana
Sr. Engineer - Facilities
Job City: Lafayette
Job State: US - Indiana
Client Project Number: 8882
Will manage facility and manufacturing engineering staff and operations management of services and processes that support the core business of GMP Center. These activities include, but are not limited to: (1) planning, designing, and managing engineering and facility construction projects while maintaining cGMP conditions for manufacturing core; (2) ensuring the most suitable working environment for employees and their activities; (3) focus on using best business practices to improve efficiency and reduce operating cost without compromising cGMP conditions; (4)Planning strategic and day-to-day operations involving manufacturing equipment, building and premises; (5) ensuring adherence to all security and safety policies.
Specific Duties and Responsibilities:
Lead, train and coach a productive team of facility and manufacturing engineers.
Troubleshooting and maintenance of pharmaceutical process equipment, HVAC, air handling, waste handling and other facility systems.
Develop and maintain the highest standards for customer satisfaction.
Cross train staff for efficient coverage of all facilities and manufacturing engineering.
Facilitate open communication and problem solving.
In consultation with the Facilities Manager, oversee the management of facility systems, infrastructure and onsite contractors to ensure that all the equipment and facilities are working properly.
Maintain accurate documentation on all facilities/files, survey drawings, building systems, lab equipment, and other records regarding the condition of the building, equipment and other systems within the building.
Manage and organize engineering task and facility support services to industry standards, as well as regulatory guidance for pharmaceutical manufacturing.
In cooperation with the Facilities Manager, maintain support system, performance of design specification, equipment calibration, preventative maintenance, and ensure validations of facility and equipment are completed timely and within required guidelines.
Provide support for major equipment/systems implementation and maintenance, repair and/or replacement. Establish standards, provide reports and follow up benchmarking, to analyze equipment, manage service contracts and review expense budgets.
Manage staff including recruiting, hiring, motivating, performance management, training and development.
Ensure adherence to security and safety procedures by participating as an active member of the safety committee.
Assist with response to emergency calls for related facility and equipment problems.
Participate in audits by local regulatory authorities including Department of Health, Wastewater, Air Pollution Control District, Fire Department, and other agencies.
Coordinate space planning and schedule relocation of personnel and furniture.
Comply with applicable State and Federal laws regarding the operation of a cGMP Facility.
Train, plan, and assign work to employee(s).
Other duties as assigned.
Demonstrated computer skills, including the use of AutoCAD, Microsoft Word, Excel, and PowerPoint
Engineering ability with regards to pharmaceutical, veterinary health, or food processing equipment
Excellent verbal and written communication skills in: one-on-one settings, small groups, and more formal settings.
Superior attention to details.
Ability to use good judgment, diplomacy, maintain confidentiality, and exercise discretion on various operational matters and customer service.
Excellent organizational skills and ability to handle successfully multiple projects / assignments.
Bachelor’s degree or equivalent and 7+ years of previous facilities experience.
Experience in maintenance/facilities trade, formal apprenticeship or on-the job training preferred.
Minimum 2+ years of supervisory experience including mentoring and leading a team.
Industry experience in GMP bio/pharmaceutical manufacturing, food processing, or veterinary health manufacturing operations is required. Ideal candidate will also have experience:
Working with major vendors and regulatory agencies.
Management of capital projects and budgets.
Writing and executing protocols for utilities engineering, utilities validation, and cleaning validations. CIP/SIP (clean & steam in place) experience in clean and 'dirty' utilities. Support utilities protocols/procedures/PLC/utilities engineering & validation protocols.
Favorable security (DEA/FBI/criminal) check and negative controlled substance test.
Regular attendance is a requirement of this position.
Possession of a valid Indiana Driver’s license.
Ability to travel (5%)