Validation Specialist

Invent Staffing; Pennsylvania; On-site; USD 80,000 - 100,000; Full time

Job summary

Join a forward-thinking company as a Validation Specialist where you will lead the execution of critical commissioning and qualification plans in a dynamic engineering environment. This role is pivotal in ensuring compliance with FDA and cGMP standards while collaborating with cross-functional teams to deliver robust solutions in the Pharmaceutical Manufacturing sector. If you have a strong background in engineering and a passion for quality assurance, this opportunity offers a chance to make a significant impact in a rapidly evolving industry.

Qualifications

• 5+ years of engineering experience in Pharmaceutical, Food, or Aerospace Manufacturing.
• Proven track record in executing Commissioning and Qualification plans.

Responsibilities

• Develop and lead execution of CQV plans and protocols.
• Collaborate closely with internal engineers and system integrators.

Skills

Engineering Experience

Commissioning and Qualification Plans

IQ/OQ/PQ Protocol Development

Automated Systems

Strong Communication Skills

Job description

• Develop and lead execution of commissioning, qualification, and validation (CQV) plans and protocols (IQ/OQ/PQ).
• Review and provide feedback on design documentation to ensure fit-for-purpose solutions.
• Perform Factory Acceptance Testing (FAT) and support Site Acceptance Testing (SAT).
• Create and maintain accurate documentation including protocols, reports, and deviation records.
• Collaborate closely with internal Capital Engineers (Process Engineers), TCS (system integrator), and OEMs to implement robust solutions.
• Support compliance efforts to meet FDA, cGMP, and internal quality standards.
• Build out project timelines and execution strategies in collaboration with SMEs and cross-functional teams.

Required Skills & Qualifications

• Minimum 5 years of engineering experience in Pharmaceutical, Food, or Aerospace Manufacturing.
• Proven track record in executing Commissioning and Qualification plans for large-scale capital projects.
• Hands-on experience with IQ/OQ/PQ protocol development and execution.
• Experience working with automated systems, robotics, or digital transformation initiatives in a manufacturing setting.
• Strong communication and documentation skills; able to coordinate with internal and external stakeholders effectively.

Preferred Qualifications

• Background in Pharmaceutical Manufacturing, particularly with Aseptic Filling Lines or Bioreactor Systems.
• Experience in FDA-regulated environments with a strong understanding of cGMP.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Invent Staffing by 2x

Get notified about new Validation Specialist jobs in Pennsylvania, United States.

USA - Validation Specialist III (Engineering) (contract)

USA - Validation Specialist II (Engineering) (contract)

Mid/Senior Level Validation Specialist/Engineer

Quality Specialist - Specialty Pharmacy (Remote)

Quality Specialist, Quality Management Systems

Philadelphia, PA $40.00-$45.00 3 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.