CQV Engineer / Validation Engineer

United Pharma; Indiana; Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

United Pharma is seeking a CQV Engineer / Validation Engineer to support change control, deviation management, and validation lifecycle activities in a regulated cGMP environment. Entry-level candidates with relevant knowledge are encouraged to apply and will work onsite with cross-functional teams.

Key responsibilities include authoring and reviewing change controls, conducting impact assessments, and ensuring compliance with GDP and cGMP standards while collaborating with QA, engineering, and

Qualifications

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related field.
• 1–3 years of experience in CQV, Validation, or Quality Engineering; entry-level candidates are encouraged to apply.
• Knowledge of change control systems, cGMP, and GDP requirements.
• Familiarity with analytical testing and chemistry is highly preferred.
• Experience with validation lifecycle activities (IQ/OQ/PQ) is a plus.
• Strong writing, documentation, communication, and problem-solving skills.
• Ability to work onsite and collaborate effectively with cross-functional teams.

Responsabilités

• Author, review, and manage change controls for equipment, systems, and manufacturing processes.
• Conduct impact assessments to evaluate product quality, validated state, and regulatory compliance.
• Support deviation management, change implementation, and validation documentation activities.
• Review technical documents and maintain compliance with cGMP and GDP.
• Support CQV lifecycle activities, including IQ/OQ/PQ, as required.
• Collaborate with Quality Assurance, Analytical Development, Engineering, and scientific teams to resolve issues and ensure timely execution.
• Participate in audits, inspections, and continuous improvement initiatives.

Connaissances

Technical writing

Documentation

Communication

Problem solving

Change control processes

cGMP / GDP knowledge

Analytical testing familiarity

Validation lifecycle (IQ/OQ/PQ)

Formation

Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related field

Description du poste

We are seeking a CQV Engineer / Validation Engineer to support change control, deviation management, and validation lifecycle activities in a regulated cGMP environment. The ideal candidate will have experience with change management, quality documentation, and cross-functional collaboration within pharmaceutical or medical device manufacturing. Entry-level candidates with relevant knowledge are encouraged to apply.

Key Responsibilities:

• Author, review, and manage change controls for equipment, systems, and manufacturing processes.
• Conduct impact assessments to evaluate product quality, validated state, and regulatory compliance.
• Support deviation management, change implementation, and validation documentation activities.
• Review technical documents and maintain compliance with cGMP and Good Documentation Practices (GDP).
• Support CQV lifecycle activities, including IQ/OQ/PQ, as required.
• Collaborate with Quality Assurance, Analytical Development, Engineering, and scientific teams to resolve issues and ensure timely execution.
• Participate in audits, inspections, and continuous improvement initiatives.

Skills and Qualifications:

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related field.
• 1–3 years of experience in CQV, Validation, or Quality Engineering; entry-level candidates are encouraged to apply.
• Knowledge of change control systems, cGMP, and GDP requirements.
• Familiarity with analytical testing and chemistry is highly preferred.
• Experience with validation lifecycle activities (IQ/OQ/PQ) is a plus.
• Strong technical writing, documentation, communication, and problem-solving skills.
• Ability to work onsite and collaborate effectively with cross-functional teams.