Packaging Technical Writer

HW Staffing Solutions; Hauppauge (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

HW Staffing Solutions is seeking a Packaging Technical Writer to prepare and review change controls, SOPs, batch records and validation reports in a pharmaceutical manufacturing environment. The role requires strong writing skills, GMP knowledge and the ability to work both independently and in a team.

The candidate should have 1–3 years of technical writing experience in pharma and a BA/BS in a related field.

Qualifications

• BA/BS degree in a related field from an accredited college/university required.
• 1–3 years of related technical writing experience; pharma manuf. preferred.
• Must be able to work in a pharmaceutical manufacturing setting.
• Ability to follow SOPs for document creation and storage; professional judgment critical.

Responsibilities

• Prepare and review change controls, deviations, methods, specs, COAs, batch records, validation protocols/reports.
• Conduct time‑studies to support packaging operations.
• Support technical writing, investigations, CAPAs, change controls and validation activities.
• Apply knowledge of lean techniques to analyze and improve packaging operations.
• Craft and refine ideas, develop sources, and produce technical documents.
• Perform data mining and analyze results to provide recommendations.
• Review content for compliance, clarity and terminology; maintain high attention to detail.
• Follow SOPs and work independently or in a team; ensure safety and compliance.

Skills

Advanced analytical skills

Effective communication

Documentation & writing

MS Office proficiency

cGMP knowledge

Prioritization & planning

Clear written and verbal English

Independent & collaborative work

Education

BA/BS in a related field

Job description

Packaging Technical Writer

Responsibilities/Accountabilities

• Prepare and review Change Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, Validation protocols/reports.
• Conduct focused time‑studies to support packaging operations.
• Support the technical writing and Packaging investigations, Corrective Action Preventive Actions (CAPAs), change controls and validation activities as required.
• Apply complete knowledge of process improvement strategies and lean techniques (e.g. Method analysis, work combination charts, ergonomics, visual controls, safety, 5S, Fishbone Diagram, Kanban, poka yoke) to analyze and improve overall packaging operations.
• Participate in the process of crafting and refining ideas, cultivating sources, and developing technical documents.
• Perform and direct data mining and analyze the results to provide recommendations or conclusions.
• Strict attention to detail and ability to review and edit content for compliance, clarity, and proper use of terminology.
• Able to follow documented SOPs for creating documents and storing them.
• Ability to work independently and collaboratively.
• Strong analytical skills with the ability to collect, organize and analyze data so that you may make recommendations and monitor performance.
• Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.
• Actively participate in Root Cause Analysis to identify areas for improvement including process redesign, workflow alignments and adjustments, and elimination of redundant and unnecessary tasks to create safe, standard, and effective action plans.
• Enforce and follow safety regulations and ensure the working area is clean.
• Adhere to CIPLA’s Safety, Health, and Environmental policies.
• Must be able to work under general supervision and able to work independently and in a team environment.
• Must be able to exercise appropriate professional judgment on matters of significance.
• Must be willing to work in a pharmaceutical manufacturing setting.
• Other duties assigned as required by Manufacturing Management.

Education Qualifications

• BA/BS degree in a related field of study from an accredited college/university required.

Experience

• Minimum One (1) to three (3) years of related technical writing experience. Preference will be given to candidates with experience in pharmaceutical manufacturing.

Skills / Competencies

• Advanced Analytical Mathematical Skills.
• Ability to communicate the needs and agenda of the packaging department to other groups.
• Excellent communications and presentation skills – written and verbal; fluent in English.
• Strong knowledge in all Microsoft office computer applications (i.e., Word, Excel, PowerPoint, etc.) and pdf to create, edit, draft and control.
• Good understanding in cGMPs, current technologies, and current FDA guidelines.
• Able to prioritize, plan and work under tight schedules and deadlines.
• Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices.
• Must communicate clearly and concisely across levels, both orally and in written.
• Strong command over written and verbal English is required.