Quality Engineering & Validation Consultant

Job Title: Quality Engineering & Validation Consultant – Pharma Manufacturing

Location: Onsite – Boston, Massachusetts

Employment Type: W2 Contract

Duration: 6 Months (Extendable)

Job Summary:

Intellectt Inc. is seeking a Quality Engineering & Validation Consultant to support a confidential pharmaceutical client in Boston, Massachusetts. This onsite contract role provides quality assurance oversight for GMP manufacturing operations and capital projects, ensuring compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements. The client name will be shared with qualified candidates during the submission process.

Responsibilities:

• Provide Quality Assurance (QA) oversight for GMP manufacturing operations and capital projects.
• Support aseptic processing activities from a quality and validation perspective.
• Lead and/or support event investigations, Root Cause Analysis (RCA), and Corrective and Preventive Action (CAPA) activities through completion.
• Collaborate with Manufacturing, Engineering, Validation, and other cross-functional teams to maintain compliance with cGMP requirements.
• Utilize quality and facilities/validation systems, including Veeva, Nuvolo, and ViewLinc, to manage documentation, deviations, and environmental monitoring data.
• Ensure documentation is accurate, complete, and inspection-ready to support internal audits and regulatory inspections.
• Promote continuous quality improvement and adherence to established quality systems and procedures.

Required Qualifications:

• Master's degree with at least 3 years of relevant pharmaceutical quality experience, or Bachelor's degree with at least 8 years of relevant experience.
• Experience working within the pharmaceutical manufacturing industry.
• Demonstrated experience providing QA oversight for GMP manufacturing operations and capital projects.
• Experience supporting aseptic manufacturing environments.
• Experience leading or supporting deviation investigations, Root Cause Analysis (RCA), and CAPA activities.
• Hands-on experience with one or more of the following systems: Veeva, Nuvolo, and ViewLinc.
• Strong knowledge of cGMP regulations, quality systems, and documentation practices.
• Strong analytical, communication, and cross-functional collaboration skills.

Work Requirements:

• Ability to work onsite in Boston, Massachusetts for the duration of the assignment.
• Participation in a video interview process.
• Two recent professional work references are required at the time of submission.
• Candidates must be legally authorized to work in the United States for the duration of the assignment without employer sponsorship, unless otherwise specified by the employer.
• Employment may be contingent upon successful completion of applicable pre-employment requirements, consistent with federal, state, and local laws.
• The employer may use automated tools as one component of the application review process. All employment decisions are made using lawful, job-related criteria and applicable human review, consistent with relevant employment laws.

Salary/Rate:

$45.00–$50.00 per hour on W2.

Good-Faith Pay Statement: In accordance with applicable federal, state, and local laws, the anticipated hourly pay range for this position is $45.00–$50.00 on a W2 basis. Actual compensation may vary based on factors such as experience, qualifications, skills, and other job-related considerations.

Benefits:

This is a contract position. Employer-provided benefits are not applicable unless otherwise required by law or specified by the employing organization.

Equal Opportunity Employer:

Intellectt Inc. and its client are Equal Opportunity Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, pregnancy, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, veteran status, military status, marital status, or any other characteristic protected by applicable federal, state, or local law. Reasonable accommodations are available for qualified individuals with disabilities throughout the application and hiring process, consistent with applicable law.

Application:

Qualified candidates who meet the requirements are encouraged to apply. Please submit an updated resume reflecting your relevant experience. The confidential client name will be disclosed to qualified candidates during the submission process. Applicants should ensure they can meet the onsite work requirements before applying.