Validation Specialist

Validation Specialist

Position Description
The Validation and Compliance Specialist will specifically be a member of QM Compliance team in preparing manufacturing and research site for converting processes, analyses, and master data to new equipment and systems

Your future duties and responsibilities
• Provides subject-matter expertise and support to QM Compliance teams as needed in the following areas:
• Take direction and work within a team.
• Develop close working relationship with SMEs and management
• Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials and product testing.
• Translate technical information and requirements into qualification/validation test design documents
• Maintains all documentation pertaining to qualification and validation. May develop procedures and/or protocols.
• Familiar with software deployment and development life cycles.
• Possess excellent customer consulting, written and communication skills.
• Learn and understand the system processes and procedures of the Customer's Stand Alone or Enterprise Computerized systems
• Document system use, processes and procedures for Customer review and approval
• Provisioning users on systems undergoing validation and document steps
• Track down root cause of errors during qualification and testing of systems undergoing validation activities and document solutions
• Assist with system configuration and changes as directed by Client Lead and document results/procedure to configure
• Demonstrates facility in client-facing activities including:
• Eliciting and documenting business requirements.
• Analyzing and validating business requirements.
• Translating business requirements into system and non-functional requirements.
• Facilitating requirements review sessions with business and IT.
• Assists business clients with developing new business processes or modifying existing business processes (during implementation, may help develop communication material; define supporting procedures and standards; document training materials; assist in the immediate training effort; etc.).
• Assists in the creation of business cases and other related financial planning, impact identification, or value justification.
• Adheres to Solution Delivery Lifecycle (SDLC) and IT Service Management (ITSM) processes.
• Develops the right skills to meet the future needs of the organization.
• Performs or assists with production support as needed.

Required qualifications to be successful in this role
• Excellent communication and interpersonal skills.
• Confident and positive attitude, able to liaise with stakeholders at all levels and navigate company culture
• Strong organizational skills, able to make good decisions in a collaborative manner
• Bachelor's degree (preferred in Biology, Chemistry, Engineering, Computer Science, or Communications) OR equivalent work experience
• GxP Manufacturing Experience and/or GxP Quality Control / Quality Assurance Experience
• Familiarity with laboratory equipment and data capture / management methods and systems
• Excellent oral and written communication and interpersonal skills
• Highly organized
• Ability to analyze, articulate and solve problems
• Ability to learn quickly, move with agility between assignments, multi-task, and to work effectively in a team environment, both face-to-face and remotely
• Ability to support internal and external projects from inception to successful implementation
• Expertise in setting and managing customer expectations
• Skill in conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management
• Strong knowledge and understanding of business needs, with the ability to establish and maintain a high level of customer trust and confidence
• Strong customer focus and ability to manage Client expectations

Minimum Education Required: Bachelors Degree (MBA or MS Preferred)

CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit-based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $48,400 - $139,300.

At CGI we call our professionals "members" to reinforce that all who join our team are, as owners, empowered to participate in the challenges and rewards that come from building a world-class company. CGI's benefits include:
• Competitive base salaries
• Eligibility to participate in an attractive Share Purchase Plan (SPP) in which the company matches dollar-for-dollar contributions made by eligible employees, up to a maximum, for their job category
• 401(k) Plan and Profit Participation for eligible members
• Generous holidays, vacation, and sick leave plans
• Comprehensive insurance plans that include, among other benefits, medical, dental, vision, life, disability, out-of-county emergency coverage in all countries of employment;
• Back-up child care, Pet insurance, a Member Assistance Program, a 529 college savings program, a personal financial management tool, lifestyle management programs and more
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Insights you can act on

While technology is at the heart of our clients' digital transformation, we understand that people are at the heart of business success.

When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees "members" because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today - one of the world's largest independent providers of IT and business consulting services.

At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.

Ready to become part of our success story? Join CGI - where your ideas and actions make a difference.

Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

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All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.

CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI's legal duty to furnish information.