Technical Writer Job at Medical Engineering Consultants (MEC) in Lexington

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge and expertise to augment and supplement their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative and corrective action and create a roadmap for ongoing future improvement by identifying, integrating and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

In this role you will be responsible for technical writing to support a site-wide initiative on CAPAs and preventing repeat deviations. These activities will play a critical role in enhancing the clarity, consistency, and compliance of GMP documentation, including but not limited to SOPs, CAPAs, and deviation records. You will collaborate with SMEs to translate technical content into user-friendly language while preserving accuracy and regulatory compliance in GMP documentation.

Scope of Work

• Review and revise existing Standard Operating Procedures (SOPs), batch records, and other GMP documents in collaboration with process owners.
• Collaborate with process owners to draft, edit, and format CAPA documentation to ensure responses are clear, actionable, and aligned with regulatory expectations.
• Work with SMEs to ensure alignment of documentation with applicable regulatory requirements (e.g., 21 CFR Parts 11 and 211), internal policies, and industry standards.
• Provide support to deviation authors or author deviations as needed to ensure documentation meets regulatory expectations.
• Participate in CAPA review meetings and audit preparation sessions to ensure alignment with site objectives and regulatory standards.
• Develop and maintain templates and style guides to improve consistency across quality system records.
• Provide training or guidance to internal teams on documentation best practices, including writing standards and formatting conventions.

BASIC QUALIFICATIONS

• Bachelor’s degree (experience may be substituted for education).
• 2+ years of Pharmaceutical/Medical Device cGMP experience.
• Ability to assess problems, identify solutions, and plan and implement necessary changes.
• Familiarity with eQMS systems (MasterControl, Veeva, etc.) preferred.
• Ability to work well in a team-oriented environment and independently.
• Great attention to detail and organizational skills.
• Ability to multi-task and meet timelines.
• Well-developed communication and technical writing skills.
• Qualified to work with controlled substances.

Physical Demands/Qualifications

• Regularly use hands to handle computerized systems and training materials.
• Use computers for an extended period each day.
• Effectively use communication by both telephone and electronic means.
• Regularly stand and walk for extended periods of time.
• Occasionally lift or move up to 25 pounds.
• Use proper lifting techniques and be conscious of work area hazards.
• Follow all site safety procedures.

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of MEC and will not be obligated to pay a placement fee.

Sponsorship is not available for this position.

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Location: Lexington, KY

Salary Range: $70,000 - $153,100