Validation Lead CaaS Engagement

Sikich

Experience: 12+ yrs
Location: Princeton, New Jersey, United States
Job type: Full-time

Required skills

TrackWise
TrackWise Digital
Salesforce
NetSuite
Emerson Syncade/DeltaV
Instruments/Equipment
Kneat
Veeva
ValGenesis
JIRA
HPALM
qTest
Azure DevOps
Tricentis Tosca
Testim

About the role

Client Solutions Princeton, New Jersey

Description

Valuation Lead CaaS Engagement

What to expect when you join Sikich

Team members at Sikich have a lot in common while also being part of a rich and varied group of contributors, creating a distinct and thriving culture. Chief among our commonalities is a desire for growth and a shared unity of purpose in our professional lives. We believe that through diverse perspectives, challenging the status quo and rewarding action, we accelerate innovation and drive growth – for our clients, for ourselves and for our communities.

The professional services landscape continues to evolve. For Sikich, this means we have an opportunity to further cement our leadership position in this industry and continue to grow our organization in increasingly exciting ways. This growth is meaningful for every team member at our company because larger companies simply see more interesting client opportunities and can attract impressively talented individuals like you. Through a dedicated focus on key business priorities and intentionally creating a rewarding employee experience, Sikich has developed into a highly regarded provider of professional services and a sought-after employer of choice.

Do you want to work with other skilled and agile practitioners who thrive on challenge and growth? We believe everyone has untapped potential. That’s why we lead with vision and act fast, pairing deep expertise with practical solutions. Our teams cut through complexity and deliver real impact. It's our hope that you find more than just a job. At Sikich, you'll find optimism, clear insights and genuine warmth, without egos.

Are you ready to grow with us?

About This Role:

The Validation is responsible for leading and managing software implementation and development projects, executing and guiding IT Quality, validation, and compliance service engagements in the Life Sciences industry. This role involves working with clients to implement new computerized systems, upgrades, and enhancements, while providing subject matter expertise in computer system validation (CSV) and Computer Software Assurance (CSA) and ensuring compliance with regulatory standards.

Experience with current digital validation tools is required, use of AI as an accelerator is a plus. Overall, a solid CSV background and a strong work ethic in an aggressive project setting will be key to being successful in this role.

Essential Job Duties:

Support creation, review, and approval of all CSV deliverables for custom in-house solutions.
Maintain close communication with stakeholders and team members to keep apprised of CSV needs, interpretation of requirements, impacts on compliance of an application, project status, and other relevant issues
Ability to create documents to an existing document standard
Obtain and respond to review by Business, IT, and Quality stakeholders
Follow SOPs and industry best practices
Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
Experience with electronic document management systems (e.g. Qumas, SharePoint etc.); application development and lifecycle management (e.g. ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow)
Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Familiarity with using AI as an accelerator for creation and review of documents and testing.

Key Competency Requirements:

Cross-functional experience in one or more regulated areas (i.e. Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired.
Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
Excellent interpersonal skills, including written and verbal communication.
Strong sense of ethics, diplomacy and discretion.
Commitment to Quality.
Strong critical thinking to analyze complex situations and discern critical issues.
Able to work effectively with highly-matrixed and multi-cultural workforce and build strong relationships by being transparent, reliable and delivering on commitments.
Excellent team player attitude.
Ability to manage competing priorities.

Knowledge, Skills, and Abilities:

Bachelor’s degree in a related field or equivalent experience.
12+ years of experience in software validation/testing in regulated environments.
10+ years of experience in CSV/CSA and GAMP 5 risk-based validation in FDA or EMA regulated environments.
Excellent understanding of GAMP 5 Risk-Based Validation Approach.
Strong understanding of Risk Assessment and Data Integrity Principles.
Knowledge of 21 CFR Part 11 and EU Annex 11 compliance.
Detail-oriented with best practices in testing and documentation in Life Sciences.
Excellent documentation and communication skills.
Must have hands-on validation experience on the following systems: TrackWise, TrackWise Digital, Salesforce, NetSuite, Emerson Syncade/DeltaV and Instruments/Equipment in Pharma/BioPharma.
Must have hands-on experience on the following VLMS: Kneat, Veeva and ValGenesis
Must have hands-on using Testing Management Testing tools such as: JIRA, HPALM, qTest and Azzure DevOps and Tricentis Tosca and Testim automated testing tool, is a plus.
Must have experience managing validation activities to implement enterprise applications by engaging global cross-functional teams
Experience with systems integrations and data migration/extraction to/from EQMS.
Ability to quickly learn new technologies and product functionality.
Experience with ISO 9001, FDA 21CFR Part 11, and EU Annex 11 compliance.
Strong leadership, consulting, and interpersonal skills.
Entrepreneurial nature with a strong sense of ownership.
Strong problem-solving and analytical skills.
Ability to manage competing priorities in a fast-paced team environment.
Team player with strong collaboration skills.

In addition, specific skills/experience required are as follows:

Values driven – You embody and model absolute integrity and servant leadership and you have a bias for action and continuous innovation.
Uncompromising problem solver – You see opportunities in every business challenge and can develop, articulate and implement solutions.
Collaboration – You are a relationship builder across all levels of the organization and across all business units.
Instills trust – You do what you say, without ego, and you follow through on commitments consistently and credibly.
Impact & influence – You are relentlessly focused on making a difference and can gain support for ideas, proposals and solutions. You get others to act, with or without formal authority, to advance initiatives and objectives.

About Sikich

Sikich offers the public and private sectors a diverse platform of professional services across consulting, technology and compliance. Highly specialized and hands-on teams deliver integrated solutions rooted in deep industry experience. Our approach is strategically and thoughtfully designed to help our clients, teams and communities accelerate success.

Sikich has approximately 2,000 team members and operates across North America, EMEA and APAC.

Sikich Total Rewards

Our team members enjoy expansive benefits ranging from competitive compensation and insurance options to wellness programs and a flexible time off policy, to name only a few. Sikich also takes pride in prioritizing team members’ health, total wellbeing and time spent with family, friends and in the pursuit of personal goals, hobbies, and endeavors.

Some examples of our many benefits:

Sikich maintains a Flexible Time Off (FTO) Policy. We encourage every full-time employee, as your role permits, to utilize paid time off (personal time, mental/physical health care, vacation, sick leave, etc.). Waiting for time off to accrue is common at other companies. At Sikich, you do not have to wait for this benefit to kick in. FTO is activated on your first day with our organization.
Sikich will also recognize paid holidays during the year and strives to permit employees to have time off the last week of the calendar year when client and project work permits.
Sikich offers a comprehensive wellness program to engage, challenge and empower team members to take responsibility for their wellbeing. Activities can be tracked through our wellness provider to obtain gift cards and other rewards.

We also offer:

Flexible work arrangements
Health, dental, vision, life, and accident/death/disability insurance options
HSA employer contribution
Nine (9) paid holidays annually.
A robust paid Parental Bonding Leave program covering birth, adoption, and foster children.
401(k) with employer contributions
CPA bonus with four (4) paid exam days & four (4) paid study days.
Tuition reimbursement
Generous employee referral bonus program
Client referral bonus program
Pet insurance
FORCE – Sikich community volunteer program enabling each team member to use up to four hours of paid time annually to volunteer and make a difference in their local communities.

Want to learn more? Visit our Careers website or Glassdoor profile.

Sikich is an Equal Opportunity Employer M/F/D/V

Sikich currently practices in an alternative practice structure in accordance with the AICPA Professional Code of Conduct and applicable law, regulations, and professional standards. Sikich CPA LLC is a licensed CPA firm that provides audit and attest services to its clients. Sikich LLC has a contractual arrangement with Sikich CPA LLC under which Sikich LLC provides Sikich CPA LLC with professional and support personnel and other services to support Sikich CPA LLC’s performance of its professional services, and Sikich CPA LLC shares certain client information with Sikich LLC with respect to the provision of such services.

About Sikich

Provides professional accounting, tax, and technology consulting services.

This page is fully interactive when JavaScript is enabled. Please enable JavaScript to apply or browse related roles.