Quality Assurance Validation Specialist (MA)

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:

Quality Assurance Validation Specialist

Location:

Devens, MA (100% Onsite)

Note: Candidate must be able to report onsite full-time.

Description of Services:

Validation & Engineering Group is seeking to provide a qualified resource to support site validation and quality oversight activities within a regulated manufacturing environment. The selected resource will be responsible for:

Reviewing and approving validation documentation and change controls in support of site operations.

Providing quality oversight for Technology Transfer, Method Transfer, Validation activities, Analytical Science and Technology, and Laboratory asset management.

Ensuring work quality aligns with applicable regulations, internal procedures, and industry guidelines.

Supporting consistent and effective use of the site change control system for all change requests.

Verifying that supporting documentation and change deliverables meet internal and regulatory requirements.

Reviewing and approving system work orders, out-of-tolerance reports (OOTs), preventive maintenance schedules, and calibration tasks.

Working independently and identifying discrepancies from standard practices, recommending and implementing corrective actions as needed.

Applying sound judgment in decision-making within generally defined practices and policies and escalating to management when necessary.

Required Skills and Qualifications:

Bachelor's degree in science, engineering, biochemistry, or a related field, or equivalent experience.

Minimum of 6 years of experience in a regulated environment, with at least 4 years focused specifically on Quality and Validation.

Strong knowledge of validation strategies, particularly for laboratory design, implementation, and startup.

Familiarity with cGMP requirements as detailed in 21 CFR Parts 210 and 211.

Understanding of general laboratory principles and scientific disciplines related to analytical, microbial, and/or bioanalytical testing.

Proven ability to work both independently and collaboratively across various levels of the organization.

Capable of providing direction and oversight to contractors as applicable.

Knowledge and application of ICH GxP guidelines for validation and quality management.

Full-time