Job Description

Technical Writer
Job Number: 22-00342
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Technical Writer for our client in Summit, NJ. 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
  • The Technical Writer, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory and clinical manufacturing operations through interaction with internal team members and internal customers as well as external service providers.
  • As a developing team player, the technical writer interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
  • The technical writer may be asked to lead small to medium sized projects in their area of responsibility and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit.
  • The technical writer will be involved in writing deviations, investigations and supporting the implementation of change controls.
Required Skills:
  • Highly proficient computer skills in Microsoft Office Suite Word, Excel, eQRMS (reliance and veeva), and Outlook with extensive background in database systems.
  • Innate ability to learn new software.
  • Strong written and verbal communication skills.
  • Highly proficient at writing well-formulated emails and notifications.
  • Ability to effectively communicate with employees, contractors and vendors.
  • Experience with technical writing and document development / generation.
  • Excellent interpersonal skills with experience dealing with a diverse workforce.
  • Strong multi-tasking ability in conjunction with proven organizational skills.
  • Ability to organize assigned tasks in a fast paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
  • Ability to effectively manage multiple tasks and activities simultaneously.
  • Familiarity with FDA and EU environments and associated compliance regulations.
  • Competencies:
    • Problem Solving
    • Team Player / Building Relationships
    • Self-Driven
    • Multi-Tasking
    • Customer Focused
    • Action and detail oriented
  • Essential Functions:
    • Draft, revise, review route and approve Standard Operating Procedures, Work Practices, Forms, and other GMP documentation.
    • Responsible for routing documents through the Client Document Management system.
    • Facilitates periodic review of SOPs and provides subject matter expertise in documentation best practice.
    • Responsible for documenting efficient procedural solutions to varied and complex challenges.
    • Attends and participates in meetings and discussions to define and capture procedures and procedural changes.
    • Writes and supports deviations and investigations that result from calibration or performance verification failures along with developing and supporting the implementation of corrective and preventative actions.
    • Captures meeting notes and tasks and notifies key stake holders in a timely fashion.
    • Keeps a log of documents and their states, including types, owner, reviewers, due dates, etc.
    • Follows up with team members and cross functional team members to encourage timely review and approval.
    • Promotes and provides excellent customer service and support.
    • Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
    • Adheres to all policies and procedures which govern the ECQ team and the equipment they manage in order to ensure compliance is held to the highest standard.
    • Promotes and provides excellent customer service and support.
    • Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
  • Regulatory Responsibilities:
    • Maintains all required Corporate, Facilities and EHS training as required.
    • Adheres to all safety procedures and hazard communication.
    • May be called upon to act as SME in both internal and regulatory audits.
  • BA / BS degree or acceptable combination of education and practical experience.
  • Minimum 3 years experience as technical writer developing procedural documentation, interfacing with stakeholders to align different and potentially conflicting needs.
  • Knowledge of cGMP in the pharmaceutical industry.
  • Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
  • Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Chris Imbien
(843) 872-9257
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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