What are the responsibilities and job description for the Senior Validation Engineer position at Element Technologies Inc?
Job descriptions of available positions are as below,
JD 1. Job Title: Validation Engineer with Lyophilizer Experience
Long Term Contract
Sanford, NC
About the Role: We are seeking a highly skilled Validation Engineer with extensive experience in lyophilization processes and equipment to join our team. The ideal candidate will be responsible for validating systems, processes, and equipment, ensuring compliance with industry standards and regulatory requirements. This role requires a strong background in lyophilization and validation activities within the pharmaceutical or biotech industry.
Key Responsibilities:
- Develop and implement validation protocols for lyophilization equipment (lyophilizers) and processes.
- Perform equipment qualification and validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Create and maintain validation documentation, including protocols, reports, and risk assessments.
- Conduct validation testing and analysis to ensure compliance with regulatory requirements and industry standards.
- Collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, and Manufacturing to ensure seamless project execution.
- Identify and resolve validation issues, implementing corrective and preventive actions (CAPA) as necessary.
- Stay current with industry trends, regulatory requirements, and best practices related to lyophilization and validation.
- Participate in internal and external audits related to validation activities.
- Provide training and support to team members on validation protocols and procedures.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- Proven experience as a Validation Engineer with a focus on lyophilization in the pharmaceutical or biotech industry.
- Strong knowledge of GMP and regulatory requirements for equipment validation.
- Excellent problem-solving skills and attention to detail.
- Exceptional communication and interpersonal skills.
- Ability to work collaboratively in a cross-functional team environment.
Preferred Skills:
- Experience with computerized system validation (CSV).
- Familiarity with validation software and tools.
- Certification in validation engineering or a related field.
- Experience with Lean or Six Sigma methodologies.
JD 2. Job Title: Equipment Validation Engineer
Long Term Contract
Sanford, NC
About the Role: We are seeking a highly skilled Equipment Validation Engineer to join our team. The ideal candidate will be responsible for ensuring that all equipment and systems used in the production process are validated and comply with industry standards and regulatory requirements. This role requires a strong background in equipment validation within the pharmaceutical or biotech industry.
Key Responsibilities:
- Develop and implement validation protocols for new and existing equipment.
- Perform equipment qualification and validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Create and maintain validation documentation, including protocols, reports, and risk assessments.
- Collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, and Manufacturing to ensure compliance with regulatory requirements.
- Conduct periodic reviews and revalidation of equipment as required.
- Identify and resolve validation issues, implementing corrective and preventive actions (CAPA) as necessary.
- Stay current with industry trends, regulatory requirements, and best practices related to equipment validation.
- Participate in internal and external audits related to equipment validation activities.
- Provide training and support to team members on validation protocols and procedures.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- Proven experience as an Equipment Validation Engineer in the pharmaceutical or biotech industry.
- Strong knowledge of GMP and regulatory requirements for equipment validation.
- Excellent problem-solving skills and attention to detail.
- Exceptional communication and interpersonal skills.
- Ability to work collaboratively in a cross-functional team environment.
Preferred Skills:
- Experience with computerized system validation (CSV).
- Familiarity with validation software and tools.
- Certification in validation engineering or a related field.
- Experience with Lean or Six Sigma methodologies.
