Documentation Specialist Automation
Indianapolis, IN, United States
Job Description
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Job Overview:
Horizon Controls Group are seeking an experienced Automation Documentation Specialist to join our team in a heavily automated biopharmaceutical setting. The successful candidate will be responsible for managing documentation related to automation systems and equipment, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:
Develop and maintain documentation related to automation systems and equipment, including design specifications, operating procedures, test plans, and reports.- Ensure compliance with regulatory requirements and industry standards, including cGMP, ISO, and FDA regulations.
- Collaborate with cross-functional teams, including engineering, automation, manufacturing, quality, and regulatory affairs, to ensure accurate and timely documentation.
- Manage change control processes for automation systems and equipment, including assessing the impact of changes on the overall system.
- Perform document control activities, including version control, tracking, and archiving of documents.
- Support validation activities, including developing and executing validation protocols and ensuring timely completion of validation activities.
- Provide technical support to manufacturing, quality, and automation teams during troubleshooting and problem-solving activities.
Requirements:
- Bachelors degree in Engineering, Science, or related field.
- 3+ years of experience in documentation management, preferably in a heavily automated biopharmaceutical setting.
- Strong knowledge of regulatory requirements and industry standards related to documentation, including cGMP, ISO, and FDA regulations.
- Experience with automation systems and equipment, including PLCs, HMIs, and SCADA systems.
- Excellent communication and organizational skills.
- Ability to work collaboratively with cross-functional teams.
Preferred Skills:
- Experience with change control processes and tools.
- Knowledge of pharmaceutical development and manufacturing processes.
- Experience with document management systems
Benefits:
PTO \xe2\x80\x93 18 days (Company Policy)
Federal \xe2\x80\x93 6 days
Employee Healthcare \xe2\x80\x93 we have four options; one of them we cover 100% for the employee
Life Insurance - Employee policy 100% covered by HCG
Long Term Disability Insurance - Employee policy 100% covered by HCG
Identity Theft Insurance - Employee policy 100% covered by HCG
401K - with a company match of up to 3.5%
HCG also offer 401K Profit Sharing
HCG Technical - Company Laptop provided if needed
HCG brand items \xe2\x80\x93 Clothing, Stationery, Quarterly care packs etc.
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Job Detail
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Job IdJD4251022
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationIndianapolis, IN, United States
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EducationNot mentioned