Technical Writer

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.

We at Eliquent Life Sciences are looking for an experienced Facilities Engineer to immediately join our Consulting Midwest team. The Facilities Engineer is responsible for authoring, reviewing, and maintaining high-quality technical documentation related to facilities engineering, GMP utilities, and infrastructure across all client sites. This includes supporting commissioning, qualification, and maintenance processes for critical systems such as HVAC, water systems, cleanroom facilities, and compressed gases. The role requires collaboration with Facilities Engineering, Quality, Validation, and Manufacturing teams to ensure all documentation meets internal standards, cGMP requirements, and regulatory expectations.

The consultant will also contribute to developing and harmonizing standard operating procedures (SOPs), change controls, work instructions, and risk assessments, ensuring inspection readiness. This candidate will sit onsite at the Madison, WI facility

Essential Duties And Responsibilities

• Develop and maintain controlled documents including SOPs, work instructions, protocols, and reports for facilities engineering, GMP utilities, and equipment lifecycle management.
• Author technical assessments, engineering change controls, and risk evaluations for facility systems, ensuring alignment with cGMP, EU Annex 1, ICH, ISPE, and ASTM standards.
• Support documentation for commissioning, qualification, and maintenance activities for facility and utility systems (HVAC, RO/DI water, cleanroom infrastructure, compressed gases, etc.).
• Collaborate cross-functionally with Quality, Validation, and Manufacturing teams to ensure facility documentation supports regulatory inspections, internal audits, and compliance readiness.
• Partner with Facilities leadership to capture technical content related to capital projects, expansions, and equipment installations into clear, accurate, and inspection-ready documentation.
• Prepare and maintain standardized templates and document control practices to ensure consistency and alignment with eGenesis quality systems (e.g., Veeva, Qualio).
• Provide documentation support for facility deviations, CAPAs, and change controls, including root cause investigations and remediation plans.
• Assist with training materials and guidance documents for facility operations and quality oversight activities.
• Ensure all documentation follows phase-appropriate regulatory expectations for both development and GMP-compliant environments
• Responsible for speaking to clients and regulatory authorities to explain investigations.
• Be able to clearly communicate on expertise to internal and external teams when needed.
• Travel may be required.
  
  

Requirements

• Bachelor's degree in science or engineering from an accredited college or university is required.
• Minimum 5-8 years previous experience with facilities, quality, and validation projects within the biotechnology and pharmaceutical industries.
• Facilities and utilities validation experience.
• Deviation and OOS Investigations initiation and completion preferred.
• Performance of Risk analysis preferred.
• Requires the ability to make significant decisions directly impacting the success of one or more projects, or adjacent workgroups/functions.
• Familiar in other areas of domain expertise within the team.
• Possesses strong organizational, multitasking, and Technical Writing abilities, with a solid background in manufacturing processes and controls.
• Experience with QMS software such as Trackwise, Veeva, or Qualio is preferred.
• Ability to work well independently and with minimum supervision.
  
  

Benefits

What We Offer:

Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.

Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.

Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.