Automation Engineer Jobs

Position Summary
The Automation Engineer is accountable for driving results in a fast-paced environment by being responsible for multiple capital and process improvement related projects.
The Automation Engineer’s primary responsibilities will center around:

• Testing automation equipment and processes (driving FAT, SAT, and commissioning activities within the Engineering Department and aiding the Validation Department with qualification efforts).
• Programming new automated components (i.e. door interlock systems, etc.).
• Evaluating and implementing new ways to automate systems that drives efficiency and compliance.
• Evaluating existing auto-generated reports for improvement and provide requirements for future auto-generated reports.

In addition, t he Automation Engineer will be responsible for managing multiple assigned capital 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 position will ensure the project accomplishes objectives by planning and evaluating project activities.
The position will be based in RTP, North Carolina (4 sterile fill lines) but also support the Wilmington, NC (Oral Solid Dose) and Charleston, SC (2 sterile fill lines) site primarily via remote support.Up to 10% travel may be required for on-site support of the Wilmington and Charleston site.
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

• Designs and/or implements modifications to the existing manufacturing equipment that will improve the operational efficiencies.
• Designs and/or implements manufacturing technology to automate production processes and equipment and supports production operations from an equipment and process troubleshooting standpoint as well as implement production efficiency improvements. Automation Engineers are expected to hold both a project management and production support workload.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Implements corrective and preventative actions to improve manufacturing’s operational efficiencies.
• Participates in internal discussions with internal customers to determine timing for project execution and sequencing of various project milestones;
• 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.
• Maintains company reputation by complying with applicable federal and state regulations. Demonstrates company loyalty in relations with company personnel.
• Leads Manufacturing Deviation investigations and applies good engineering practices to reduce the risk of repeat Non-Conformances.
• 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.
• Designs, installs, and supports the validation of the automated control system for new or upgraded utilities systems, compounding processes, and filling equipment.
• Performs risk assessment and risk mitigation activities using systematic tools.
• Requests bids from contractors and suppliers by working with procurement group, recommends best provider.
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Manages multiple capital projects concurrently.
• Provides facilities and utilities support for new or modified equipment used to manufacture new active pharmaceutical ingredients.
• Composes Functional Requirement Specifications (FRSs) for new or upgraded utilities systems, compounding processes, and filling equipment.
• Generates and revises standard operating procedures.
• Provides technical support for and lead safety and quality improvement initiatives.
• Formalizes CAPEX document preparation and submission.
• Provides support to the Validation in the generation and execution of Installation and Operational Qualifications (IOQ) and Performance Qualifications (PQ).
• Programs PLCs, HMIs, SCADA systems, and inspection systems.
• Acts as engineering and technical lead for key plant projects.

Education And Experience

• Minimum 4 years’ experience in Automation / Controls Engineering.
• Previous work experience in a sterile manufacturing environment preferred.
• Master’s Degree in Engineering, Engineering Management, or related field preferred
• Experience with robotics, AI and machine learning.
• Experience with project management.
• Bachelor’s Degree in Engineering or related field required.

Alcami Non-Negotiables

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

Alcami Core Leadership Competencies

• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• 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.
• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• 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.
• 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

• Ability to perform complex math functions, compute ratios, rates and percentages.
• Exemplary knowledge of discrete machine control; AB Safety PLCs, Gearboxes, Safety Circuits, Pneumatics, etc.
• The following are highly desired
• Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.
• 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..
• Ability to keep up with the latest technologies.
• Solid understanding of computer programming and software development.
• Proficiency with Microsoft Office applications.
• Strong analytical skills.
• Receives minimal instruction on day-to-day work, general instructions on new assignments.
• Mastery of Data Historian
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Ability to work with people at all levels of the organization.
• Strong leadership and problem-solving skills.
• Excellent verbal communication and presentation skills required.
• Ability to troubleshoot equipment and perform complex system tests.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
• Ability to draw and interpret graphs and charts.
• Proficiency in maintaining automation equipment.
• Ability to perform assigned tasks carefully and on schedule according to standard operating procedures and supervisor’s instructions.

Travel Requirements

• Up to 10% 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.
What We Offer You:

• 401(k) with company match
• Bonus plan
• Competitive salary with career advancement opportunities
• Medical, dental and vision coverage from day one
• Voluntary benefits including short & long-term disability, life, accident, critical illness insurances
• Company paid vacation, holiday and sick-leave

Diversity and Inclusion:
Alcami values diversity and we are c ommitted to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.