Position Summary

The Project Engineer (Automation) is accountable for driving results in a fast-paced environment by being responsible for multiple capital and process improvement related projects. The Project Engineer (Autmation) will be responsible for managing multiple assigned projects including critical utilities installation, process improvements, equipment installation and other capital projects while performing all related activities to ensure such efforts adhere to schedule, meet budget and accomplish the defined scope. This role is responsible for supporting and leading projects (capital, utilities, equipment, process improvement efforts) which includes working with cross-functional departments to understand the scope and needs of the project and developing the project implementation plan within budget and schedule guidelines. This individual will design for quality compliance, safety and adherence to company standards as well as customer contract requirements. This position will ensure the project accomplishes objectives by planning and evaluating project activities.

The Project Engineer (Automation) provides day-to-day performance monitoring and feedback and is responsible for full management of scoping, design, bid analysis, along with fiscal management of each project and a group of projects to meet all financial and schedule targets. The Project Engineer (Automation) creates and maintains various reports and documents to measure the status of each of his/her projects. The Project Engineer (Automation) serves as the day-to-day manager of both small and high-profile projects that are often complex, fast-track projects and often occurring while the buildings are occupied and operating. The Project Engineer (Automation) partners with executives, managers and staff to work on various aspects of planning, evaluating (cost/benefit), managing operational impacts of the project and evaluating ongoing operational aspects. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• To design and implement manufacturing technology to automate production processes and equipment and to support production operations from an equipment and process troubleshooting standpoint as well as implement production efficiency improvements. Project Engineers (Automation) are expected to hold both a project management and production support workload.
  • Project Management: Engineering responsibilities include developing user and design requirements, selecting equipment vendors or completing the technology design and equipment build in-house, managing the installation of automation while ensuring safety, and supporting the validation of the automated system for adherence to requirements, CGMPs, and intended system operation.
  • Production Support: Support Maintenance Technicians in situations where troubleshooting or technology may fall outside of their area of expertise. Interact with production supervisors/managers to identify areas to improve equipment throughput, flexibility, quality, safety, and/or reliability. Implement automation solutions resulting from deviations, investigations and/or CAPA assignments.
• Compose Functional Requirement Specifications, FRSs, for new or upgraded utilities systems, compounding processes, and filling equipment.
• Design and implement modifications to the existing manufacturing equipment that will improve the operational efficiencies
• Complete financial justification and ROI calculations and work with production to complete capacity analysis and cost justification scenarios.
• Act as engineering and technical lead for key plant projects.
• Provide technical support for and lead safety and quality improvement initiatives.
• Program PLCs, HMIs, SCADA systems, and inspection systems.
• Manage multiple capital projects concurrently.
• Manage the budget for multiple capital projects and proactively identify opportunities to reduce the overall project cost.
• Design, install, and support the validation of the automated control system for new or upgraded utilities systems, compounding processes, and filling equipment.
• Provide support to the Validation to in the generation and execution of Installation and Operational Qualifications (IOQ) and Performance Qualifications (PQ).
• Generate and revise standard operating procedures.
• Lead Manufacturing Deviation investigations and apply good engineering practices to reduce the risk of repeat Non-Conformances.
• Implement corrective and preventative actions to improve manufacturing’s operational efficiencies.
• Perform risk assessment and risk mitigation activities using systematic tools
• Participates in internal discussions with internal customers to determine timing for project execution and sequencing of various project milestones;
• Provides facilities and utilities support for new or modified equipment used to manufacture new active pharmaceutical ingredients.
• Requests bids from contractors and suppliers by working with procurement group, recommends best provider.
• Formal CAPEX document preparation and submission.
• Controls project plan and maintains project schedule by closely monitoring project progress; coordinating activities on critical path.
• Controls project costs by approving expenditures; administers contracts and monthly expenditures against planned cash flow.
• Prepares project status reports.
• Responsible for commissioning and coordinating of equipment/areas in preparation for validation activities.
• Maintains company reputation by complying with applicable federal and state regulations. Demonstrates company loyalty in relations with company personnel.
• Maintains a safe, clean and organized work environment free of safety hazards.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

• Bachelor’s Degree in Engineering or related field required.
• Master’s Degree in Engineering, Engineering Management, or related field preferred
• Minimum 4 years’ experience in Automation / Controls Engineering.
• Previous work experience in a sterile manufacturing environment preferred.

Alcami Non-Negotiables

• Consistently demonstrates honesty and integrity through personal example.
• Follows all safety policies and leads by example a safety first culture.
• Produces high quality work product with a focus on first time right.
• Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

• Mastery of a variety of automation software applications. Software applications include but are not limited to the Allen-Bradley RSLogix portfolio, Allen-Bradley RSView, GE Proficy SCADA/HMI iFix, Siemens S7, Modicon, Wonderware, and Cognex In-Sight Explorer
  • The following are highly desired
    • Exemplary knowledge of discrete machine control; PowerFlex Drives, AB Integrated Motion (Kinetics), AB Safety PLCs, Gearboxes, Safety Circuits, Pneumatics, etc.
    • Exemplary knowledge of process control; S88 programing architecture, AB phase manager, GE Prophecy iBatch
    • Mastery of SFC, Ladder, FBD, and structured text programing languages
    • Background in Computer Integrated Manufacturing data collection (DDE, OPC, Transaction Mangers)
    • Mastery of Oracle, SQLServer relational databases
    • Mastery of OSI Pi Data Historian or GE Prophecy iHistorian
• Able to perform assigned tasks carefully and on schedule according to standard operating procedures and supervisor’s instructions.
• Ability to work with people at all levels of the organization.
• Ability to perform complex math functions, compute ratios, rates and percentages.
• Ability to draw and interpret graphs and charts.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Excellent verbal communications and presentation skills required.
• Proficiency with Microsoft Office applications.

Decision Making and Supervision Required

• Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.
• Receives minimal instruction on day-to-day work, general instructions on new assignments.

Travel Requirements

• Up to 5% domestic travel required.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 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, peripheral vision, depth perception and ability to adjust focus. The noise level is moderate to noisy. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.