QA Validation Specialist

Job Description

A large pharmaceutical client is looking for a validation specialist to join the team in Albany, NY. This person will support equipment qualification activities across filling equipment, isolators, formulation systems, and analytical instruments. The role involves developing lifecycle documentation such as user requirement specifications, design qualifications, alarm criticality assessments, and equipment qualification assessments. A significant portion of the early workload will focus on technical writing, drafting validation protocols, and preparing compliant documentation. As execution begins, this specialist will be on the manufacturing floor performing IQ/OQ activities, following GDP with precision, documenting data accurately, and reviewing completed protocols prior to approval. They will work closely with manufacturing, engineering, and validation teams, communicate technical information clearly, and ensure qualification activities are carried out correctly and efficiently.

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Skills and Requirements

• 2+ years of hands on experience with equipment qualification in a biopharma environment, including filling equipment, isolators, formulation equipment, and analytical instruments

• Solid understanding of Installation Qualification (IQ) and Operational Qualification (OQ)

• Experience generating and managing lifecycle documentation such as URS, DQ, equipment qualification assessments, alarm criticality assessments, and validation protocols

• Proven technical writing skills for drafting clear, compliant validation documents

• Ability to explain complex technical topics in simple, understandable terms

• Experience within biopharmaceutical manufacturing environments

• Strong on the floor execution skills with strict adherence to GDP

• Proactive learner who actively engages in training and skill development - Experience with electronic validation protocol drafting or electronic execution systems

• Familiarity working in teams responsible for qualification of filling equipment

• Background involving isolators, sterile manufacturing, or contamination controlled environments