Engineering Documentation Manager
Indianapolis, IN, United States
Job Description
b'
Job Overview:
Horizon Controls Group are seeking an experienced Engineering Documentation Manager to join our team in a bio pharmaceutical setting. The successful candidate will be responsible for managing the development and maintenance of engineering documentation, including Standard Operating Procedures (SOPs), technical reports, and regulatory documents, to support the design, development, and manufacturing of pharmaceutical products.
Key Responsibilities:
Develop and maintain engineering documentation processes and procedures to ensure compliance with regulatory requirements and industry standards.- Oversee the development and maintenance of engineering documentation, including design specifications, SOPs, validation protocols, and technical reports.
- Collaborate with cross-functional teams, including engineering, manufacturing, quality, and regulatory affairs, to ensure accuracy, completeness, and compliance of engineering documentation.
- Manage document control systems, including document revision, distribution, and storage.
- Ensure timely and accurate completion of documentation, including the review and approval of documents.
- Conduct training on documentation processes and procedures to ensure compliance and consistency across the organization.
- Provide technical writing and editing support for engineering and scientific documents, including regulatory submissions.
Requirements:
- Bachelors degree in Engineering, Science, or related field.
- 5+ years of experience in engineering documentation management, preferably in a pharmaceutical or biotech industry.
- Strong knowledge of regulatory requirements and industry standards related to engineering documentation, including cGMP, ISO, and FDA regulations.
- Experience with document control systems and electronic document management systems (EDMS).
- Excellent communication and project management skills.
- Ability to work collaboratively with cross-functional teams.
Preferred Skills:
Experience with technical writing and editing, including authoring and reviewing engineering documents.- Knowledge of pharmaceutical development and manufacturing processes.
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.
Beware of fraud agents! do not pay money to get a job
MNCJobz.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.
Related Jobs
Job Detail
-
Job IdJD4252651
-
IndustryNot mentioned
-
Total Positions1
-
Job Type:Full Time
-
Salary:Not mentioned
-
Employment StatusPermanent
-
Job LocationIndianapolis, IN, United States
-
EducationNot mentioned