Process Engineer (Holy Springs, North Carolina)

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. 

Essential Functions:

• Provide engineering, troubleshooting support and technical expertise for process equipment and site utilities as needed. 

• Proactively identify engineering problems or opportunities and apply technical expertise to develop and present feasible solutions.

• Lead and manage new equipment/systems installation including infrastructure, connectivity and capacity assessments. 

• Lead and manage process improvements, corrective and preventive actions (CAPAs) and change controls implementation for process equipment and site utilities.

• Lead the identification of new equipment including but not limited to proper type, size, materials of construction, throughput, operational conditions, physical dimensions, required utilities, waste requirements, user requirements specifications (URS) and others.

• Support new product introductions (NPIs). 

• Work with process sciences in developing new equipment/systems/process design, controls, requirements, specifications and drawings. 

• Liaison with CAPEX team for the implementation of capital projects. 

• Coordinate execution of projects, improvements and other engineering activities. 

• Oversee contractors when implementation and/or corrections are required. 

• Works with QA/QC to ensure proper testing, inspection and release after completion of engineering activities. 

• Support equipment IQ/OQ/PQ or any other validation/commissioning startup activity as required. 

• Ensure new equipment operates in compliance with required EHS, regulations and codes. 

• Develop, write, edit and/or review in collaboration with Facilities SOPs, P&IDs and maintenance procedures for new equipment and/or systems. 

• Communicate efficiently with Contractors, Suppliers, OEM providers as well as internal equipment owners and operators for a successful operation of the FDBT facility.

• Able to work with other contractors, manufacturing, validations and quality control personnel regarding changes or improvements to the systems. 

• Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility, and document out of specification conditions with deviations, CAPAs and Change Controls as appropriate. 

• Continuously stay current with assigned SOPs and keep up to date training file ensuring compliance with all applicable Standard Operating Procedures. 

• Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, site procedures and job performance qualifications. 

• Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities.

• Maintain a positive, professional, and customer-oriented attitude. 

• All other duties as assigned. 

Required Skills & Abilities: 

• Able to identify potential problem areas of equipment that is malfunctioning, using technical manuals or mechanical, electrical or controls knowledge. 

• Demonstrate leadership, technical aptitude, and problem-solving skills. 

• Must be flexible and able to manage multiple priorities and tasks. 

• Must be results driven and goal oriented with the ability to manage risks. 

• Knowledge and understanding using P&IDs, equipment manuals, specifications, SOPs, and be able to use proper judgment when implementing projects or taking corrective actions during equipment malfunctioning. 

• Strong analytical and problem-solving skills. Possess or have the ability to apply these skills to resolve technical problems and to gain knowledge with respect to the operation and maintenance of various utility/process systems. 

• Must be able to develop, and draft operational procedures and maintenance procedures for technical (utilities/process) equipment using the OEM manual and system knowledge. 

• Possess or have the ability to gain knowledge of FDA, OSHA, EH&S, EPA, and state of Texas requirements. 

• Must be able to use project management software such as Microsoft Project. Proficient with MS Office products (Word, Excel, Outlook, PowerPoint). 

• Knowledge of regulatory requirements for manufacturing of pharmaceutical products. 

• Strong written and verbal communications skills with the ability to effectively communicate within cross-functional teams and to upper management. 

• Ability to organize and present technical overviews to engineering staff, cross functional departments, and upper management. 

• Be self-starter, self-motivated, detail oriented and possess interpersonal skills. 

• Ability to learn quickly and work effectively with little supervision when needed. 

• Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility. 

• Knowledge of bio-medical, bio-technical equipment, both upstream and downstream highly desirable.

• All other duties as assigned. 

Qualifications Requirements/Knowledge/Education/Skills:

• Bachelor’s Degree preferably in Electrical, Chemical, Mechanical or Biomedical Engineering

• Six (6) years of qualified experience in an engineering role in an FDA regulated research or manufacturing facility 

Physical Requirements and Working Environment: 

• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell. The employee may lift and/or move up to 50 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus. He / she may frequently work inside weather conditions, near moving mechanical parts, exposed to wet and or humid conditions, and an odorous atmosphere, may be exposed to fumes and the risk of electrical shock, and occasionally work on ladders in high places, in small spaces, such as lift/metering stations, manholes, tanks and wet wells.