Job SummaryInteract with a team of multiple subject matter experts to generate, review, update and route validation documentation. Act as a local expert for department teammates and technical writer staff in regard to requirements for documentation deliverable generation, requirements and routing across multiple manufacturing sites.
Essential Duties and Responsibilities- Plan, develop, organize, write, edit and review operational procedures and validation documentation.
- Communicate appropriately with customers (internal and external) to determine documentation requirements
- Clear, error-free and accurate standard documentation
- Develop documentation across multiple projects and teams simultaneously.
- Adhere to quality management system regulations and guidelines.
- Analyze documents to maintain continuity of style of content and utilize good documentation practices.
- Study products and processes and consult subject matter experts to gather data.
- Generate and review a variety of manufacturing and inspection equipment validation deliverables, including, but not limited to: protocols, reports, specifications, manuals, work instructions, procedures, qualifications (IQ, OQ, PQ), engineering studies (Process Development, confirmation or exploratory studies) and production documentation.
- Generate high-quality, easily understood technical documents, meeting minutes and presentations
- Utilize software to route and control documents for revisions and approval of technical literature.
- Maintenance of knowledge around procedures and other documentation according to all internal SOP's and guidelines
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- onitiate and support intra and internal department meetings and projects to achieve team goals
- Support meetings and activities in which project documentation requirements or templates are discussed
- Support and contribute in Lean Sigma programs and activities towards team goals
- Maintain engineering records and documents as required
Education- Bachelor's Degree Technical Writing Field preferred
Work Experience- Minimum 5 years experience with Process Engineering required
Preferred Knowledge, Skills and Abilities- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company's safety policy at all times
- Able to comply with the company's quality policy at all times.
License and Certifications- Manufacturing\Lean Six Sigma Certification-IASSC Lean Certification of any level Upon Hire preferred
Travel Requirements10%: Up to 26 business days per year
Physical RequirementsLight-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.
Additional Requirements- Has superior analytical, organizational, leadership and technical skills
- Ability to assert technical solutions and standards
- Self-motivated, results- and solution-oriented personality
- Must have excellent written and verbal skills
- Excellent interpersonal skills: good team player and individual contributor as well
- Interpret data, read and write, effective communication, decision making, presentation skills
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