Jobs for People with MS: National MS Society

xpericneJob Title: Validation Specialist

Job Description

Position Overview: We are seeking a Validation Specialist to join our team for a new project involving the retrofitting of a clinical API manufacturing space to create a new milling suite. This role requires compiling information, writing specification documents, and executing protocols. The Validation Specialist will be responsible for writing installation qualification, operational qualification, and performance qualification protocols, as well as summary reports.

Responsibilities

• Retrofit an area in the clinical API manufacturing space to create a new milling suite. This includes reducing large particles of powder into smaller particles, with specific exposure requirements and controlled facility conditions such as differential pressures and air locks.

• Compile information, write specification documents, and execute protocols. This includes writing installation qualification, operational qualification, and performance qualification protocols, as well as summary reports.

• Install an isolator and milling equipment, ensuring the actual mill heads that pound the powder are placed inside the isolator.

• Collaborate with the facilities management engineering department for space modifications, process utilities for qualification, and the quality assurance organization for document review and approval.

• Report directly to the project lead and work independently, providing direction to other team members who assist with protocol execution.

Essential Skills

• Strong validation includes experience in writing and executing protocols and understanding the validation lifecycle.

• Experience with GMP documentation is crucial, as the role involves creating and managing detailed documentation in a regulated environment.

• At least five years of experience in validation engineering.

• Comfortable using Microsoft suite of products for document creation and management.

• Experience in a regulated environment, with a strong understanding of documentation and compliance requirements.

Additional Skills & Qualifications

• Familiarity with electronic document management systems.

• Experience in other regulated industries, such as submarine manufacturing, is acceptable if candidates are comfortable with documentation requirements.

Work Environment

The role involves a mix of office and fieldwork. Documentation preparation is done in an office environment, while protocol execution occurs in the manufacturing space. PPE requirements for the role are minimal, including safety glasses and a lab coat. Prescription glasses must have side shields and be ballistic-rated if used as safety glasses. The initial training period is approximately two months, covering electronic tools, systems, and SOPs. The core business hours are from 7 AM to 4 PM, with flexibility for an 8 to 8.5-hour work period within that timeframe. The team typically starts early and finishes by around 3 PM. The position is primarily onsite, but there is potential for remote work depending on the individual's ability to manage their time effectively. Remote work is possible for tasks like documentation preparation.

Pay and Benefits

The pay range for this position is $30.00 - $50.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • 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 Andover,MA.

Application Deadline

This position is anticipated to close on Apr 25, 2025.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.