Senior Facilities Engineer

Biospectra Inc•Bangor, PA

15d

About The Position

BioSpectra is seeking a Senior Facilities Engineer to lead facility related projects and assist departmental management in driving a high level of performance excellence. This role is critical for a growing company that is a major supplier to the bio-pharmaceutical industry.

Requirements

Degree in Chemical, Mechanical, Facilities Engineering or other related field.
A minimum of five or more years’ experience with a manufacturer of products and/or ingredients in life science, biopharmaceutical, food, or fragrance industries.
Facility Project Management: Managing projects related to building, upgrading, expanding or installing equipment in a manufacturing setting.
Facilities & Production Equipment Maintenance: Experience monitoring and maintaining facilities and production-related equipment.
Electrical & HVAC: Technical expertise with respect to HVAC and electrical equipment and systems.
Computer Maintenance Management Systems: Working knowledge of computer maintenance management systems (CMMS).
Computer Aided Design: Working knowledge in the use of computer aided design software and related technology.
Equipment Design & Selection: Experience and knowledge in the engineering and design of facilities related equipment and systems and the selection of facilities related equipment.
Process Improvement Expertise: Demonstrated achievement in driving continuous improvement in the designing of integrating utilities, building and equipment layout for manufacturing.
Achieves Results: Results-oriented leadership with a proven ability to deliver tangible outcomes and measurable results on the commercialization of products.
Problem-Solving & Decision-making: Demonstrated technical and mechanical ability to diagnose, decide on a course of action and resolve manufacturing process issues and mentoring the process technology staff to do the same.
Developing and Executing a Strategy: Demonstrated ability to develop and execute a process validation strategy, ensuring all manufacturing locations remain in compliance with cGMP and other regulatory requirements.
Communication: Ability to write, orally communicate and effectively communicate technical information in a concise and understandable way.
IT Technology: Demonstrated ability to use IT software technology and systems, including statistical software to drive process performance excellence.

Nice To Haves

A working knowledge of SPC, DOE, Six Sigma, Lean and/or other process improvement methodology and systems would be ideal.
An effective working knowledge of validating facilities related equipment consistent with FDA guidance and cGMP requirements.

Responsibilities

Lead facility, utility and production room upgrades and construction, facility expansions and equipment installations.
Plan, budget and lead the execution of facility, utility and equipment installation projects.
Coordinate communication regarding status, planned actions, issues and plans to resolve assigned project related issues.
Direct the design for production room changes, facility upgrades and equipment installations. Review drawings and information prepared by the CAD department.
Prepare engineering drawings and P&IDs using the CAD system.
Prepare 3D models for conceptual design, space configurations and equipment layouts to support facility planning, project design and facility requirements.
Ensure facility and equipment designs optimize the use of space and the total cost of maintenance.
Monitor the on-going performance of BioSpectra electrical and HVAC systems. Reports on key performance indicators (KPIs) to track progress and identify areas for improvement.
Identify and resolve facility related issues promptly, applying sound engineering principles and problem-solving skills.
Direct the selection, oversee the performance of, and addresses gaps in the performance of outside vendors who perform work on behalf of the Operations department.
Select appropriate utilities equipment and provide guidance regarding the selection of production equipment related to equipment upgrades, facilities build-outs and any other facility-related changes, considering the impact to quality, performance and cost-effectiveness.
Executes facility related equipment validations and establishes requirements to ensure facility related equipment remains in a qualified state, maintaining documentation and overseeing re-qualification activities as needed.
Assist the departmental management in hiring, motivating and building the capabilities of the operations and maintenance departments.
Oversee the quality of work and performance of the facilities team and coaches and recognize individuals as appropriate.
Direct the facilities and maintenance staff to abide by good housekeeping practices and comply with OSHA safety and health regulations.
Develop and implement strategies for continuous process improvement related to facilities, utilizing methodologies to enhance efficiency and quality.
Directs the development and implementation of efficient and cost-effective processes and utility systems to meet current and future operational needs of the organization.
Monitor the reliability of all facilities and production-related equipment to minimize unplanned equipment downtime.