Validation Engineer - Intellectt INC

Job Title: Validation Engineer

Location: Pottstown, PA

Overview: Seeking a skilled and experienced Validation Engineer to join our team at a leading biotech facility. This long-term position offers an exciting opportunity to contribute to the validation and qualification of critical equipment and processes within a dynamic and innovative environment. The ideal candidate will have a strong background in validation, with experience in installation, operation, and performance qualifications, as well as proficiency in writing cGMP documentation and procedures.

Key Responsibilities:

• Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ):

  • Execute and document IQ, OQ, and PQ activities for equipment and systems.
  • Ensure all qualifications are conducted in compliance with regulatory standards and internal procedures.

• cGMP Protocols and Reports:

  • Develop and author cGMP protocols, reports, and qualification documents.
  • Maintain accurate and detailed records of all qualification activities.

• cGMP Procedures:

  • Write and update cGMP procedures for the operation of equipment and processes.
  • Ensure procedures meet regulatory requirements and industry best practices.

• Preventive Maintenance Plans:

  • Create and maintain preventive maintenance plans for equipment.
  • Collaborate with maintenance teams to ensure the effective implementation of maintenance activities.

• User Requirement Specifications (URS):

  • Develop and author User Requirement Specifications to define equipment and system requirements.
  • Work closely with stakeholders to ensure requirements are accurately captured and documented.

• Change Controls:

  • Initiate and lead change control processes for the implementation of new equipment and systems.
  • Manage change control documentation and ensure compliance with regulatory standards.

Qualifications:

• Education:

  • Bachelor's degree in Engineering or a science-related field.

• Experience:

  • Minimum of 5 years of industry experience in validation roles.
  • At least 2 years of direct experience in Commissioning, Qualification, and Validation (CQV) activities.

• Skills:

  • Proficiency in authoring cGMP protocols, reports, equipment operation instructions, URS, and preventive maintenance plans.
  • Strong understanding of regulatory requirements and industry standards for validation.
  • Excellent analytical and problem-solving skills.
  • Strong communication and teamwork abilities.

• Additional Requirements:

  • Ability to work independently and manage multiple projects simultaneously.
  • Detail-oriented with a commitment to maintaining high standards of accuracy and compliance.