Technical Writer jobs in Janesville, WI

Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs.  We are a growing organization with a bright future, and we are looking for motivated and experienced team members.  We offer a comprehensive benefits and a generous Paid Time Off package.  

The primary purpose of this position is to guide internal and external clients through the stages of the drug development and commercialization processes as they relate to manufacturing operations.  This position is responsible for providing Operations SME support for product launch activities that will be executed within the manufacturing operations areas that include but are not limited to aseptic processes, BFS equipment optimization, and support of the training department within the Woodstock facility to ensure a smooth development and transition from the Product Development group to the Operations group. This position will act as a support role to both NPD & Operations management ensuring that the needs of Operations to effectively commercialize products are included at the start of projects.

• Demonstrate technical proficiency as Operations SME, an ability to collaborate with others, and independent thought.
• Work with multi-disciplinary project teams, comprising representatives from relevant functions.
• Create reliable cost-effective processes for operational execution.
• Build Continuous Improvement into new PD processes with the engagement of employees and using incremental improvements so that processes are designed with concepts of poka-yoke, one-touch product flow, repeatable/reproducible, easy, practical, flexible, and people focus. 
• Participate in PM teams as an Operations representative, cross-site teams, and functional teams in the PD/Operations Departments, Site or Global PM projects, activities, and initiatives. 
• Work with NPD, Engineering, Maintenance, Operations, and Quality as needed to ensure new and existing processes are able to deliver quality products.
• Provide regular and timely status updates to Operations Management function, when requested provide and supply updates to Site Leadership and clients. 
• Escalate unresolved issues, potential barriers to project/activity progression, and resource constraints to management. 
• Support on-site client meetings as required. 
• Communicate any changes in the commercialization/tech transfer program with the internal team members and ensure that the changes are fully documented.
• Comply with Health, Safety and Environmental responsibilities for the position.
• Maintain effectiveness of the Quality Control System components relevant to this position.
• Displays higher degree of independent judgment and analyses to complete the responsibilities of the role
• Other tasks as assigned. 

Education or Equivalent: 

Experience:  

Knowledge/Skills Requirements:  

• Knowledge of Operations, Pharmaceutical and Biotech industries.
• Excellent communication – written and verbal.
• Excellent client facing skills – desire to meet and exceed client expectations.
• Proficient with MS Office Programs.
• Ability to work with minimal supervision to meet required timelines.
• Ability to prioritize and manage multiple projects/tasks.
• Mathematical and reasoning ability.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to work effectively under pressure to meet deadlines. 
• Demonstrated ability to read, write, and speak clear English.

Physical Requirements:  

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.  
• Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment.  
• Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Business Environment:  

• Fast paced
• Performance driven
• Customer focused
• Collaborative and inclusive

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.