Commissioning/Qualification Specialist/Specific Commissioning and Validation Support

Job description

• W2-only
• Fully Onsite

1. POSITION PURPOSE AND SCOPE

The Validation Engineer plays a key role in ensuring the successful deployment of laboratory equipment and systems across multi-use sites by collaborating with both internal teams and external service providers. This position is integral to advancing milestones related to the qualification of facilities, utilities, and equipment. Working independently with minimal supervision and broad guidance, the engineer will handle routine tasks, apply basic analytical skills, and resolve common problems of limited complexity. As a growing team contributor, the individual will interact with their supervisor and colleagues to support team goals while fostering strong, collaborative relationships with stakeholders outside the immediate team.

2. REQUIRED COMPETENCIES

Knowledge, Skills, and Abilities:

• Technical Writing: Strong ability to produce clear, concise, and technically accurate documents using Microsoft Word, adhering to site validation standards. Excellent attention to detail in grammar, punctuation, spelling, and overall document quality.
• Critical Thinking and Process Orientation: Ability to approach tasks with a process-focused mindset, utilizing critical thinking skills to improve existing strategies and develop new solutions.
• cGXP Compliance: Solid understanding of cGXP (current Good Manufacturing Practice) guidelines and documentation standards as they apply to systems, equipment, and instrumentation in the pharmaceutical industry.
• 21 CFR Part 11 Knowledge: Familiarity with 21 CFR Part 11 regulations regarding electronic records and signatures.
• Document Creation & Procedure Writing: Experience drafting SOPs (Standard Operating Procedures), Work Instructions, and Risk Assessments related to pharmaceutical production processes, manufacturing equipment, and facility systems.
• Qualification/Validation Experience: Demonstrated experience in authoring and executing commissioning, qualification, and validation documents, including plans, protocols, system requirements, traceability matrices, and summary reports.
• Specialized Qualification Experience (Preferred): Experience with temperature/humidity mapping qualifications for controlled storage areas, temperature-controlled units (e.g., incubators, refrigerators, freezers), and cryogenic storage systems.
• Airflow Visualization Experience (Preferred): Experience executing airflow visualization qualifications (e.g., smoke studies) for biological safety cabinets, isolators, and controlled manufacturing areas.
• Problem-Solving and Documentation: Proficient in writing protocol deviations, investigating out-of-specification results, implementing corrective and preventive actions, and managing change controls.
• Collaboration: Strong interpersonal skills for effective cross-functional teamwork.
• Time Management: Ability to prioritize tasks in a fast-paced environment, manage multiple responsibilities simultaneously, and ensure timely completion of tasks.
• Communication: Excellent written and verbal communication skills, including the ability to write well-structured emails, reports, and presentations. Capable of interpreting engineering manuals and drawings and conveying information clearly to employees, contractors, and vendors.
• Software Proficiency: Skilled in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams) and quick to learn new software tools. Experience with Blue Mountain Regulatory Asset Manager and Veeva Vault is a plus.

3. DUTIES AND RESPONSIBILITIES

• Manage smaller-scale projects with defined scope and complexity.
• Author and execute qualification/validation deliverables, including system assessments, plans, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities.
• Document protocol deviations, investigate non-conformance issues, perform root cause analysis, implement corrective and preventive actions, and handle change controls.
• Develop and maintain written procedures for the operation, cleaning, and maintenance of equipment and systems.
• Ensure all documentation complies with BMS standards and policies.
• Provide exceptional customer service, maintaining positive relationships with all team members and site stakeholders, and contributing to a collaborative team environment.

4. EDUCATION AND EXPERIENCE

• A Bachelor's degree (BA/BS) is required, preferably in a scientific or engineering discipline.
• At least 4 years of experience in equipment qualification and technical writing within an FDA-regulated industry (pharmaceutical, medical device, or biotechnology) is required.

JOB ID: 80919