Consultant 1 - Technical Writer (Columbus)

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.

The ETHOS Program is a foundational training, mentorship, and development program designed to prepare early career professionals to navigate complex Life Science projects and contribute to ELIQUENT’s mission and client success.

An ETHOS Consultants' primary responsibility is to provide clients with professional services under supervision.

Responsibilities:

Technical Writing

Write technical documentation for clients under supervision including but not limited to:

Writing procedures, investigations, protocols, reports, change controls, CAPAs, etc. to support the Maintenance, Engineering, Validation, Quality, and Regulatory departments. Documents are reviewed by mentors or senior consultants.

Generating validation documents for qualification of facilities, utilities, equipment or instruments and processes including cleaning, sterilization, shipping, and manufacturing including protocols and reports. Documents are reviewed by mentors or senior consultants.

Writing and revising technical documents to support qualification activities including SOPs, validation/verification master plans, guidelines and execution plans, automation test plans, engineering design reviews, commissioning, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), site acceptance test (SAT) and/or commissioning test procedures.

Service Delivery

Performs on site or support work for a client under supervision, including but not limited to:

Qualification and Validation protocol execution

Thermal mapping of temperature-controlled chambers, warehouses, and sterilization processes

Investigations and deviations

Risk analysis, and/or failure mode and affect analysis

Data integrity assessments and review of client data

Executes protocols and helps resolve deviations/discrepancies, analyze study data and write summary reports, under supervision of senior consultants.

Problem Solving

Provides solutions to routine technical problems with limited scope under supervision of senior consultants.

Supports the resolution of regulatory observations or manufacturing site issues.

Time Management

Responsible for tracking time to budget and notifying supervisors of any issues on deliverables.

Carries out duties in compliance with all local, state, and federal regulations and guidelines including the FDA, EPA, and OSHA.

Complies with all internal and client site policies and procedures.

Successfully completes job training requirements.

Individuals must represent Eliquent at client sites and interact confidently with clients, contractors, management and peers.

Requirements, Education, and Qualifications:

Maintains technical knowledge by attending educational workshops and/or reviewing publications

Other duties as assigned by Sr. Management

Quality:

Adhere to all Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP).

Training & Development:

Ensure training has been received before undertaking specific duties and that all training is documented in training records.

Health & Safety:

Understand the company’s Health & Safety Policy and follow all associated procedures.Report all accidents or awareness of any unsafe conditions in the workplace to supervisor or management.

Human Resource Management:

Conform to the company’s policies contained in the Employee Handbook

Familiarity with aspects of validation

Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form

Ability to define problems, collect data, establish facts and draw valid conclusions

Proficient in Microsoft Word, Excel, and PowerPoint

Basic understanding of FDA and cGMP regulations and documentation practices

Familiarity with pharmaceutical manufacturing or bioprocessing equipment

Familiarity with laboratory instrumentation

Preferred experience:

Work or internship in a regulated industry such as pharmaceuticals, biotechnology, or medical device

Required Education:

Bachelor's degree in engineering (Chemical, Biomedical, Mechanical) preferred, Bachelor’s in biology or chemistry may be considered with additional experience.

Additional Qualifications:

Customer service/client relations

Communication proficiency

Attention to detail

Can work productively independently with minor supervision

Self-motivated, flexible, dependable and available

Excellent organizational and time management skills

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.

Salary: 75k-80k

Part Time