Description

How will you make an impact? As a Technical Writer, you will be an important part of a cross-functional team tasked with aiding the site's operational team in problem-solving, process implementation, and investigative management, both independently and collaboratively. In this role, you will provide critical support to the manufacturing operational team by addressing daily quality issues and leading various initiatives, agendas, and projects.

What will you do? Develop precise and concise work instructions tailored to technical and scientific manufacturing procedures. Innovate and formulate procedures that align with product specifications and uphold thorough quality standards. Analyze historical production records and manufacturing documents to capture relevant data and insights into existing processes. Prepare investigation and root cause analysis reports per established quality standards. Develop close collaboration with manufacturing department personnel to resolve optimal document formats and identify methods, protocols, and standard methodologies to integrate into the instructions. Create and maintain documents using an electronic document management system. Ensure adherence to SKU data standards and supply chain prerequisites that impact SKU configuration. Collaborate with team members to efficiently distribute workloads, manage project progress, and conduct thorough reviews of colleagues' work to ensure accuracy. Own the design of validation documents and lead their implementation to completion. Lead initiatives for the implementation of Corrective and Preventive Actions (CAPA) to rectify deviations and address customer complaints. Apply internal software systems, including ERP, SKU Wizard, and Product Lifecycle Management, to lead the creation and modification of raw materials, sub-assemblies, and finished goods SKUs, ensuring accurate alignment with current manufacturing processes.

How will you get here? Education: Bachelors degree in Sciences or Engineering

Experience: 2+ years of experience developing and editing engineering documentation for production workflows and manufacturing records. Proven experience evaluating and editing SOP's and other documentation for accuracy and comprehension Proven ability to write multiple Work Instructions and Validation Reports that align with product specifications and regulatory standards 3+ years of experience in a manufacturing environment or similar role 2+ years of experience in an ISO or cGMP-regulated manufacturing environment 2+ years of experience in technical writing Proficiency with ERP systems and a basic understanding of cost accounting and standard manufacturing financials Familiarity with Practical Process Improvement (PPI) Systems and tools (or equivalent Continuous Improvement and Lean Systems) Previous experience working with multifunctional teams on projects of varying complexity Understanding of manufacturing processes and inter-departmental responsibilities

Knowledge, Skills and Abilities: Proficient in Microsoft Office Software, particularly Excel, Word, and PowerPoint Collaboration skills and the ability to effectively influence others Excellent verbal and written communication skills Thrives in a fast-paced work environment Consistently meticulous and precise in performing responsibilities Maintains a positive demeanor towards the job and colleagues Results driven and data-focused Proficient in understanding manufacturing operational flows, including but not limited to Formulations, Protein Purification, Antibody Manufacturing, Filling, and Assembly/Packaging Possesses robust project management skills Proactively anticipates needs and identifies solutions to problems

Pay and Benefits

The pay range for this position is $34.00 - $34.00

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Carlsbad,CA.

Application Deadline

This position will be accepting applications until Dec 27, 2024.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.