Automation Engineer

About ALK

ALK is a forward-thinking allergy company with a long tradition for allergy innovation. We are making a bold move into digital to transform the way consumers, patients, and healthcare professionals address allergies. ALK is devoted to improving quality of life for people with allergies by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) - a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction.

Since 1923, we have been working to improve the quality of life for allergy patients by developing products that target the cause of allergy. With over 2,200 employees and subsidiaries, production facilities and distributors worldwide we are in a unique position to further the advancement of allergy treatments. The company is publicly traded on NASDAQ OMX Copenhagen (OMX: ALKB) with global headquarters in Horsholm, Denmark and US Offices in Round Rock, TX, Bedminster, NJ, Port Washington, NY, Post Falls, Idaho, Luther, OK, Oklahoma City, OK and Mississauga, Canada.

ALK has an opening for a full-time Automation Engineer, located in our Oklahoma City, OK facility.

Area of Responsibilities

• Manages the scope, deliverables, schedule, budget and quality of engineering projects related to cGMP production equipment and systems.
• Prepares and develops User Requirement Specifications for automated equipment, software, and systems.
• Manages the design, implementation, and qualification of automation systems
• Supports QA/validations through preparation of design documents and protocol review.
• Recommends and manages implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes.
• Experience on Automation Systems and processes; involved in different phase of definition, deployment, integration or qualifications:
• Development of projects of Automation, Control and Instrumentation (PLCs, sensors etc)
• Familiar with Data Acquisition Systems, SCADA, and OPC network design and operations
• Acts as company department liaison for IT/ OT forums and global teams
• Lean Manufacturing and Historical data Systems (KPIs)
• Software Management and Support for production equipment, vision systems, labelling, and Packaging
• Evaluates, approves, prepares and executes change control documentation.
• Acts as Subject Matter Expert during regulatory inspections.
• Supports manufacturing and maintenance activities as technical advisor.
• Ability to troubleshoot, repair, and maintain automation/ control systems on various packaging, manufacturing, and facility system
• Maintains clean and safe working environment by enforcing EHS policies and procedures.
• Maintains company reputation by enforcing compliance with local, state and federal regulations.
• Other duties may be assigned.

Competences

Competences required to fulfil the area of responsibilities and work assignments:

Education:

• Bachelor's degree or relevant experience in pharmaceutical engineering
• Formal training in project management preferred

Experience:

• 5+ years manufacturing experience or equivalent combination of education and relevant experience
• Demonstrate proficiency with industry project management practices and tools
• Ability to analyze data and make conclusions based on the data
• Able to work in a team across departments and sites
• Clear understanding of other team members roles and responsibilities
• Ability to represent the department or organization in local and global IT projects with assistance from other cross functional team members
• Ability to work independently
• Proven effective leadership abilities
• Identifies opportunities for improvement and makes constructive suggestions for change to improve both project management and/or process effectiveness
• Demonstrate initiative and good interpersonal skills, able to work in a team
• Ability to work with Quality Systems and regulatory requirements such as: CFRs, GMP, FDA, OSHA
• Must be able to travel domestically and internationally, as needed
• Must be creative and flexible
• Must have good attention to detail
• Proven ability to understand and follow written and verbal instructions in English
• Demonstrated ability to comply with required safety practices
• Understanding of validation principles and applications for computer systems, equipment and PLC's

ALK is an Equal Employment Opportunity / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance