Mid/Senior Level Validation Specialist/Engineer

Katalyst Healthcares & Life Sciences; Marietta (PA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Mid/Senior Level Validation Specialist/Engineer to join their team. This role involves developing and executing validation lifecycle deliverables in the clinical trials of drugs, biologics, and medical devices. The ideal candidate will have a strong background in commissioning and qualification, with excellent technical writing and communication skills. This position offers the opportunity to work closely with university hospitals and pharmaceutical companies, making a significant impact in the healthcare sector. If you have a passion for ensuring quality and compliance in clinical research, this is the perfect opportunity for you.

Qualifications

• Minimum of five years of experience in commissioning and qualification.
• Experience with Aseptic Fill Finish Equipment or Lyophilizes is essential.

Responsibilities

• Develop and execute validation lifecycle deliverables for clinical trials.
• Ensure adherence to ISPE C&Q guidelines throughout the project.

Skills

Aseptic Fill Finish Equipment

Technical Writing

Communication Skills

Interpersonal Skills

Commissioning and Qualification

Tools

Kneat e-validation software

Job description

Mid/Senior Level Validation Specialist/Engineer

Katalyst Healthcare & Life Sciences is hiring entry-level candidates for several contract research positions in the Clinical trials of drugs, biologics, and medical devices.

We have immediate job opportunities available in the fields of Drug Safety, Pharmacovigilance, and Clinical Research. We collaborate with university hospitals, pharmaceutical companies, and recruiting partners.

1. Prior experience with Aseptic Fill Finish Equipment or Lyophilizes is required.
2. Strong technical writing, verbal, and written communication skills.
3. Excellent interpersonal skills for interaction with client employees.
4. Responsible for developing and executing validation lifecycle deliverables related to this project.
5. Minimum of five (5) years of experience with commissioning and qualification, including adherence to ISPE C&Q guidelines.
6. Knowledge of Kneat e-validation software is preferred.

All your information will be kept confidential according to EEO guidelines.