Technical Writer/Validation Specialist

Location: Raleigh Consulting

Job Description

Job Description:

 

Technical Writing:

 

  • Generates and executes life cycle documentation (FAT, SAT,

IOQ, PQ) for cleaning, shipping, facilities, utilities, systems,

equipment and processes for (re)qualification/(re)verification.

 

  • Writes, reviews and revises a variety of Installation, Operation

and Performance qualification/verification related documents,

including any of all of the following: SOPs, validation/verification

master plans, guidelines and execution plans, automation,

engineering design, commissioning, qualification or other

technical documents, user requirement specifications (URS),

functional requirement specifications (FRS), detailed design

specifications, factory acceptance test documents (FAT),

verification protocols, and/or commissioning test procedures.

 

  • Writes reports to summarize validation/verification/commissioning

and/or revalidation/verification/commissioning activities.

 

  • Writes procedures, investigations, protocols, reports change

controls, etc. to support the Maintenance and Engineering

departments

 

  • Writes, and executes protocols, resolves deviations/ discrepancies,

reviews and analyzes study data, writes summary reports.

 

Soft Skills:

 

  • Handling multiple responsibilities and job tasks (multi-tasking) as needed.
  • Demonstrating attention to detail.
  • Flexibility with work requirements, work environment and fast-paced/changing job needs.
  • Customer service oriented
  • Excellent written and verbal communication skills
  • Excellent technical writing skills
  • Strong interpersonal skills and the ability to work in a team environment
  • Strong project management skills

 

Promoting teamwork by:

  • Collaborating with co-workers.
  • Attending staff meetings as required.
  • Meeting individual company goals as established.
  • Establishing rapport and maintaining positive communication with others, demonstrating
  • respect and support, cooperating and flexibility with change.
  • Adhering to company and department policies.

 

Required Education:

 

Bachelors Degree in engineering, science, or related field

 

Required Work Experience:

  • 3-6 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
  • Experience in executing protocols including systems such as Process Validation, utilities,

manufacturing equipment and basic knowledge of laboratory validation

 

Preferred experience:

  • Experience with many aspects of validation

 

Required Knowledge:

  • Working knowledge of FDA and cGMP regulations and documentation practices
  • Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
  • 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
  • Preferred Knowledge:
  • Working knowledge of FDA and cGMP regulations and documentation practices
  • Familiarity with temperature mapping
  • Familiarity with executing protocols including systems such as Process Validation, utilities,
  • manufacturing equipment and basic knowledge of laboratory validation


About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.


Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!



Apply Now