Equipment Validation Specialist
Job
Actalent
Falmouth, MA (In Person)
$98,800 Salary, Full-Time
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Job Description
Position Summary The Validation Engineer is responsible for supporting equipment and process validation activities within a regulated manufacturing environment. This role ensures that procedures, documentation, and validation protocols comply with regulatory requirements and accurately reflect current operational practices. The Validation Engineer will work cross-functionally with departmental supervisors, engineering, quality, and manufacturing teams to complete validation tasks on schedule and maintain documentation accuracy within the electronic document management system (EDMS). Key Responsibilities Project Coordination & Task Execution Collaborate with department supervisors to ensure validation tasks are completed within established timelines. Support engineering and project-related activities as assigned. Documentation & Procedure Management Develop, revise, and maintain procedures and forms within the EDMS. Ensure documents accurately represent current processes and reflect necessary revisions or improvements. Equipment & Process Validation Prepare, execute, and document validation activities, including engineering studies, validation protocols, and final reports. Validate commonly used equipment such as lyophilizers, centrifuges, balances, moisture meters, freezers, temperature-mapped cold rooms, ovens, dishwashers, robots, pipetting robots, and filling machines. Data Analysis & Technical Support Collect, interpret, and analyze data to support engineering decisions, troubleshooting efforts, and validation documentation. Utilize statistical methods for data analysis where appropriate. Change Control Management Initiate, manage, and support change control activities across systems, equipment, and processes. Training & Compliance Support Train staff on validation procedures, protocols, and documentation. Maintain compliance with internal quality systems and external regulatory requirements. Skills & Competencies Validation & equipment validation Process validation & validation testing GMP / regulated industry experience Medical device or pharmaceutical documentation practices Strong technical writing and communication skills Clear data presentation skills Excellent troubleshooting and problem‑solving abilities High attention to detail and strong organizational skills Ability to work independently and collaboratively in cross-functional teams Experience with electronic document management systems Familiarity with statistical data analysis (preferred) Qualifications Bachelor's degree in Science, Engineering, or a related field - or - an equivalent combination of education and experience. Minimum 1 year of experience in a medical device, pharmaceutical, clean room, or biotech manufacturing environment. Experience working in a regulated environment; knowledge of FDA cGMP and/or ISO standards is a plus. Job Type & Location This is a Contract position based out of East Falmouth, MA. Pay and Benefits The pay range for this position is $45.00 - $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 East Falmouth,MA.
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