Careers

Application Submission

Positions available at this time are:

Validation Engineer

Job Description:

Validation Engineering support in the areas of document development, commissioning, and qualifications of facilities, laboratory, utilities, and equipment. Expected to work independently with minimal guidance and demonstrate the ability to multi-task, problem-solve, and communicate effectively and efficiently in a dynamic and challenging environment.

Responsibilities:

• Generate, review, and approval of lifecycle documents such as Impact/Risk Assessments, User Requirements, Design/Functional Specifications, Traceability Matrix, Criticality Assessments, Part 11 Assessments.
• Full-cycle generation, commissioning, and execution of IQ/OQ/PQ Protocols
• Generate, review, and approve validation plans, protocols, and reports
• Validation test execution and deviation reporting
• Collaborate with stakeholders, engineers, SMEs, and cross-functional team members in equipment qualification efforts
• Author/revise validation SOP’s
• Assess Change Controls for validation impact
• Assist in the investigation and remediation of quality events related to qualified equipment

Qualifications:

• Experience in pharmaceutical or biopharmaceutical/biotechnology cGxP environment. A combination of equipment qualification, process validation, computer systems, cleaning, sterilization, and packaging is acceptable
• Quality experience with in-depth knowledge of validation approach, cGxP standards and risk-based validation
• Working knowledge of pharmaceutical and medical device facilities
• Must have direct experience in the commissioning, qualification, and validation of facilities, utilities, production, laboratory, and support equipment
• Knowledge of industry guidelines, US and International regulations (FDA, cGMP, ISO, etc.) for validation of GMP facilities
• Must have strong verbal, written, and interpersonal communication skills especially needed to work in a cross-functional role

Education: 

Bachelor’s degree in Engineering or related scientific discipline with 5+ years of pharmaceutical and/or biotechnology experience in Validation, Quality, MFG, or Engineering

Project Manager

Job Description:

The Project Manager manages key client projects. Project management responsibilities include the coordination and completion of projects on time within budget and within scope. Oversee all aspects of projects. Set deadlines, assign responsibilities, and monitor and summarize the progress of the project. Prepare reports for upper management regarding the status of the project.
The successful candidate will work directly with clients to ensure deliverables fall within the applicable scope and budget. He or she will coordinate with other departments to ensure all aspects of each project are compatible and will hire new talent as needed to fulfill client needs. May require a bachelor’s degree and 2-4 years of experience in the field or in a related area. Familiar with a variety of the field’s concepts, practices, and procedures. Rely on limited experience and judgment to plan and accomplish goals. Perform a variety of tasks. Lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department. Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.

Responsibilities:
• Coordinate internal resources and third parties/vendors for the flawless execution of projects
• Ensure that all projects are delivered on time, within the scope, and within budget
• Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility
• Ensure resource availability and allocation
• Develop a detailed project plan to monitor and track progress
• Manage changes to the project scope, project schedule and project costs using appropriate verification techniques
• Measure project performance using appropriate tools and techniques
• Report and escalate to management as needed
• Manage the relationship with the client and all stakeholders
• Perform risk management to minimize project risks
• Establish and maintain relationships with third parties/vendors
• Create and maintain comprehensive project documentation
• Meet with clients to take detailed ordering briefs and clarify specific requirements of each project
• Delegate project tasks based on junior staff members’ individual strengths, skill sets and experience levels
• Track project performance, specifically to analyze the successful completion of short and long-term goals
• Meet budgetary objectives and make adjustments to project constraints based on financial analysis
• Develop comprehensive project plans to be shared with clients as well as other staff members
• Use and continually develop leadership skills
• Attend conferences and training as required to maintain proficiency
• Perform other related duties as assigned
• Develop spreadsheets, diagrams and process maps to document need

General Requirements:
• Proven working experience in project management
• Excellent client-facing and internal communication skills
• Excellent written and verbal communication skills
• Solid organizational skills including attention to detail and multitasking skills
• Strong working knowledge of Microsoft Office
• Project Management Professional (PMP) / PRINCE II certification is a plus
• Bachelor’s Degree in appropriate field of study or equivalent work experience
• GMP Background
• Pharmaceutical Experience a must

Skills & Proficiencies:
• Developing and Tracking Budgets
• Coaching
• Supervision
• Staffing
• Project Management
• Management
• Process Improvement
• Planning
• Performance Management
• Inventory Control
• Verbal Communication

Senior SCADA Automation Engineer

Job Description

The Senior SCADA Automation Engineer is responsible for designing, developing and introducing of systems to effectively utilize state-of-the-art developments encompassing various engineering related fields and associated products. The Senior Scada Automation Engineer ensures a consistent, coordinated and cohesive project engineering approach to Automation, SCADA, and Communication systems.

General Requirements

• Experience of managing automation projects
• Detailed knowledge of automation system architectures.
• Experience supporting PLC, SCADA and HMI systems in a manufacturing environment.
• Coding\development\troubleshooting experience with programmable logic controllers (PLCs).
• Experience maintaining control networks and interfaces based on Ethernet and fieldbus topologies.
• Practical database experience, scripting, or general familiarity with virtualization technologies and IT skills is desirable.
• Experience in Pharmaceutical or relevant GMP manufacturing environment.
• A strong knowledge of the GAMP guidelines applicable to computer system validation.
• Bachelor’s Degree in engineering, computer science, or related field
• Knowledge of industry standard protocols such as IEC (61850, 60870-5), non-IEC (DNP3, Modbus), and related cyber security (IEC 62351, NERC CIP).
• Working knowledge of modern control systems (SCADA, RTUs, PLCs)
• Knowledge of programming languages including VBA, SCIL, C, C++ and C

Senior Automation Engineer

Job Description

The Automation/Controls Engineer will develop programs which require Process, Automation and Motion Control. This encompasses handling of the complete electrical design from conception to implementation. As an integral member of our technical team, responsibilities include designing, managing, commissioning, budgeting, and testing process systems and equipment.

Areas of proficiency should include: Process Control, Automation Control, Electrical Engineering, VMware, ThinManager, SQL Reporting, SCADA, Servo Motion Control, PLC, HMI, AC Motors, Stepper, Robotics, and Vision.

Responsibilities

As an integral member of our technical team, responsibilities include designing, budgeting, commissioning, and testing process systems and equipment. Additional responsibilities include developing programs which require process, automation, and motion control including complete electrical design from conception to implementation.

Requirements

• Siemens 7 – 1500 PLC programming utilizing TIA (Totally Integrated Automation portal) is mandatory. Siemens VFD experience a plus!
• BS in Electrical or Computer Science Engineering from an accredited university or equivalent experience
• 5+ years of industrial experience
• Proven ability to work as part of a design engineering team to take a preliminary concept to buildable design, including PLC hardware design, instrumentation, control devices, network design, and PLC and HMI Programming
• Startup and commissioning of PLCs, SCADA/HMI, and network systems as they apply to process equipment, including the debug of hardware and software
• Project management experience and Proficiency with AutoCAD
• Prior experience with VMware, ThinManager, SQL Reporting
• Prior experience with Rockwell Automation Allen-Bradley, Siemens, GE, and Modicon
• Prior experience with Rockwell Automation FactoryTalk View SE, Wonderware Archestra, GE iFIX is a plus
• Prior experience with Vision Systems and Robotics is a plus
• Prior experience in a Pharmaceutical and GMP environment a plus

Senior Application Engineer

Position Overview

IAS is an independent control systems integrator requiring engineers to be independently responsible for their everyday schedule and project timeline. This individual will be required to interface directly with the customer in regards to overall project design/scheduling. In addition, they must have 5 + years of extensive knowledge in application development utilizing WonderWare System platform 2012R2 and 3 + years for 2014R2. This knowledge must include InTouch for System Platform and WonderWare Historian Server. Knowledge of WonderWare MES/Performance software would be a plus. Other requirements include certification with VMware Data Center Virtualization and Cloud Infrastructure. This includes vSphere, vCenter Server and VMware ESXi. Refer to Essential Job Functions below for additional requirements. This individual should remain open minded when it comes to the latest in automation solutions and from time-to-time will be required to travel overnight for training or customer onsite commissioning.

Essential Job Functions

• Servo design, development, and troubleshooting experience of advanced motion control systems including multi-axis, coordinated axis applications is a must.
• 5+ years of application development with Wonderware System Platform 2012R2. Certification is preferable.
• 3+ years of application development with Wonderware System Platform 2014R2. Certification is preferable.
• 5+ years of application development with Wonderware InTouch for System Platform. Certification is preferable.
• 5+ years of application development with Wonderware Historian Server. Certification is preferable.
• Certification with VMware Data Center Virtualization and Cloud Infrastructure. This includes vSphere, vCenter Server and VMware ESXi.
• The ability to deploy a windows domain controller, including remote user and user groups authentication from a variety of 3rd party devices.
• Excellent customer communication skills.

Non-essential Job Functions

• Flexible schedule including casual overtime.
• Available to work over holidays and weekends if required for plant shutdowns.
• Ability to travel to our Wilson office for meetings, design reviews, etc.
• Overnight travel for training and customer onsite commissioning.
• Knowledge of WonderWare MES/Performance software would be a plus.

Requirements

• Available to work in Garner, NC office.
• Available between the hours of 8 am and 5 pm.
• Ability to work independently with minimal supervision.
• BS in Electrical or Computer Science Engineering from an accredited university or equivalent experience
• 5+ years of industrial experience
• Proven ability to work as part of a design engineering team to take a preliminary concept to buildable design, including PLC hardware design, instrumentation, control devices, network design, and PLC and HMI Programming
• Startup and commissioning of PLCs, SCADA/HMI, and network systems as they apply to process equipment, including the debug of hardware and software
• Project management experience and Proficiency with AutoCAD
• Prior experience with VMware, ThinManager, SQL Reporting
• Prior experience with Rockwell Automation Allen-Bradley, Siemens, GE, and Modicon
• Prior experience with Rockwell Automation FactoryTalk View SE, Wonderware Archestra, GE iFIX is a plus
• Prior experience with Vision Systems and Robotics is a plus
• Prior experience with Pharmaceutical Packaging and GMP is highly desirable