Job Number: 21-14728
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!
- The Validation Technical Writer will work cross-functionally with Facilities, Engineering, Manufacturing, and Quality groups to lead Equipment Commissioning and Qualification (ECQ) deviation investigations to support qualification of equipment, utilities, facility and laboratory instruments used in CAR T manufacturing.
- Additionally, Technical Writer will also be responsible for working with the Manufacturing, Facilities, Engineering teams to agree on appropriate CAPSs as needed.
- Finally, the Validation Technical Writer will be responsible for wring, revising and review of all related GMP documentation for ECQ including qualification protocols for equipment/utilities/facility/lab instruments (IOQ, OQ, PQ), User Requirement Specifications (URS), Requirements Traceability Matrixes (RTM), Validation Summary Reports (VSR), etc
- Lead ECQ deviation investigations to ensure on time closure
- Draft/revise IOQ, PQ protocols, RTMS, VSR, URS, etc.
- Participate in cross-functional deviation and CAPA meetings and initiatives in S12
- Demonstrated ability to collaborate with Manufacturing Operations, QA, Facilities, MS&T, and other groups to appropriately assign deviation investigations and CAPAs, and support closure
- Identify opportunities to streamline the deviation investigation process for thorough, efficient investigations
- Support documentation archival
- Other duties may be assigned, as necessary
- Understanding of equipment/utilities/facility/lab instruments qualification/commissioning process. Knowledge of cell culture, cryopreservation, and aseptic processing for cell therapy drug products is a plus
- Knowledge of deviation management tools and techniques (e.g. five whys, fish-bone, etc.)
- Knowledge of cGMP/FDA regulated industry
- Basic mathematical skills
- Strong technical and compliance writing capability
- Proficient in MS Office applications
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Previous experience leading and closing equipment/utilities/facility/lab instruments deviation investigations.
- Master’s degree plus 2 years of experience Manufacturing Technical Writing and/or Validation or Bachelor’s degree plus 3-4 years of experience in Manufacturing Technical Writing and/or Validation or Associate/ Medical Technical degree and 8 years of Manufacturing or Operations experience
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:
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.