Are you looking for an exciting opportunity to develop your manufacturing skills in a growing, international pharmaceutical company? At ALK, we are on a mission to improve the lives of people living with allergies, and we are seeking a dedicated and driven Automation Specialist to join our Automation Department.
Your key responsibilities:
Automation Specialist supports all production activities regarding automated processes, systems and equipment on-site to ensure work is performed and ensures compliance with corporate requirements and site policies. Key responsibilities include:
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Provide support to the areas associated with qualified systems.
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Lead changes related to qualifications when modifications affect the qualified status of equipment or systems.
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Perform initial qualifications of computerized equipment and systems.
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Ensure qualified status is maintained through periodic reviews according to evaluated frequency.
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Provide support in handling deviations, especially those impacting the qualified status of equipment in production and utilities areas.
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Manages the scope, deliverables, schedule, budget and quality of engineering projects related to cGMP production equipment and systems.
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Manages the design, implementation, and qualification of automation systems.
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Maintains company reputation by enforcing compliance with local, state and federal regulations.
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Work closely with global IT teams to ensure adherence to corporate cybersecurity policies and global system design standards.
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Prepares and develops User Requirement Specifications for automated equipment, software, and systems.
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Supports QA/validations through preparation of design documents and protocol review.
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Recommends and manages implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes.
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Experience on Automation Systems and processes; involved in different phase of Definition, deployment, integration or qualifications:
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Development of projects of Automation, Control and Instrumentation (PLCs, sensors etc).
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Lean Manufacturing and Historical data Systems (KPIs).
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Software Management and Support for production equipment, vision systems, labelling, and Packaging.
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Evaluates, approves, prepares and executes change control documentation and validation documentation.
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Acts as Subject Matter Expert during regulatory inspections.
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Maintains clean and safe working environment by enforcing SHE policies and procedures.
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Maintains company reputation by enforcing compliance with local, state and federal regulation.
Your profile:
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Education: Degree in Engineering, Electronics and industrial automation, or related technical field.
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Experience: Minimum 5 years in pharmaceutical engineering or validation roles.
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Proven ability to understand and follow written and verbal instructions in English.
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Knowledge of GMP and qualification principles.
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Knowledge in production OT systems and IT architectures.
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Experience with systems, utilities and production equipment.
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Demonstrate proficiency with industry project management practices and tools.
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Strong documentation and organizational skills.
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Ability to lead technical changes and manage cross-functional communication.
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Ability to analyze data and make conclusions based on the data
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Able to work in a team across departments and sites
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Clear understanding of other team members roles and responsibilities
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Ability to represent the department or organization in local and global projects with assistance from other cross functional team members.
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Identifies opportunities for improvement and makes constructive suggestions for change to improve both project management and/or process effectiveness.
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Demonstrate initiative and good interpersonal skills, able to work in a team.
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Ability to work with Quality Systems and regulatory requirements such as: CFRs, GMP, FDA, OSHA.
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Demonstrated ability to comply with required safety practices.
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Understanding of validation principles and applications for computer systems, equipment and PLC’s.
We provide:
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Competitive salary package.
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Career development opportunities and continuous trainings.
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Stable employment and a positive work environment.
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A comprehensive benefits package including health insurance, subsidized meals, and a pension plan.
If you’re excited about building a better future in health, ALK is the right place for your ambitions.
