Sr Assoc, Process Validation
About The Position
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will your help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Requirements
- Minimum 5 years experience with Process Engineering required
- 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
Nice To Haves
- Technical Writing Field preferred
- Manufacturing\Lean Six Sigma Certification-IASSC Lean Certification of any level Upon Hire preferred
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
- Initiate 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
Benefits
- Benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
