AI Success™

Job Description

It's an onsite.

The Analytical Validation Specialist III will assist in validation activities, including but not limited to software updates, new system introduction, and decommissioning of analytical systems. The individual will work closely with Senior Analytical Validation Specialists and other functional groups to contribute to quality and right-first-time performance. This role requires close support from other Subject Matter Experts and Management.

Key Responsibilities:

Assist in validation activities for software updates, new system introductions, and system decommissioning.
Collaborate with Senior Analytical Validation Specialists and cross-functional teams to ensure quality and efficiency.
Support the development and execution of validation protocols and reports.
Conduct risk assessments and ensure compliance with regulatory requirements.
Troubleshoot and resolve validation issues in a timely manner.
Maintain accurate documentation of validation activities.
Provide training and support to junior team members and other departments as needed.

Qualifications:

Bachelor's degree in Chemistry, Biochemistry, or related field.
Minimum of 5 years of experience in analytical validation or related field.
Strong understanding of validation principles and regulatory requirements.
Excellent analytical and problem-solving skills.
Strong attention to detail and ability to work independently and as part of a team.
Effective communication and interpersonal skills.

Preferred Qualifications:

Master's degree in Chemistry, Biochemistry, or related field.
Experience with validation of analytical systems in a regulated environment.
Knowledge of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).

About PharmEng Technology

PharmEng Technology, now part of Efor Group, leader in Compliance Engineering, is a leading provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.

As part of Efor’s global network of 3,000 experts across 12 countries, we are better equipped than ever to deliver innovative and comprehensive solutions tailored to the unique needs of clients worldwide. This integration strengthens our ability to combine global expertise with local proximity, positioning PharmEng as a strategic partner for the industry’s most prominent players.

Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique challenges.

At PharmEng Technology by Efor, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives, developing customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.

Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical, and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).

Industry

Chemicals & Materials

Company Size

201-500 employees

Headquarters

Toronto, CA

Year Founded

Unknown

Website

pharmeng.com

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