Sr. Systems Validation Specialist / Lead Validation Engineer

Job Description

Description

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

We empower and support our colleagues

We commit to client success at every turn

We have the courage to do the right thing

We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.

We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Overview: The Senior Systems Validation Specialist will work as part of the Global Quality Large Molecule Analytical Science (GQLMAS) group and drive a culture of quality and operational excellence across the GQLMAS West Point and North Wales labs. This role will work with a team of metrology and equipment coordination specialists supporting the maintenance and qualification of analytical equipment and instrumentation within the GMP and non-GMP environment.

The successful candidate must function both independently and collaboratively in a fast-paced, integrated, multidisciplinary team environment. Strong communications skills and eagerness to adapt and learn are essential attributes. As a member of the team, you will be joining scientific and technical problem solvers who are dedicated to creating the life-changing medicines of tomorrow.

Job Responsibilities:

Project and Task Management: Develop and manage project plans for metrology and validation tasks, ensuring alignment with strategic goals and timelines. Understand project requirements, delegate tasks among team members based on expertise and project demands and ensure effective execution without direct supervision. This includes ensuring adherence to project milestones and quality standards

Strategic Planning and Mentorship: Leverage expertise in metrology to provide strategic direction for equipment validation projects, ensuring best practices are implemented and maintained. Additionally, mentor and coach junior scientists while overseeing day-to-day assignments under the direction of the Director, Analytical Metrology & Validation, Global Quality Large Molecule Analytical Science (GQLMAS)

Collaboration and Compliance: Collaborate with scientific teams across Global Quality and external partner groups to drive compliance and operational excellence

Laboratory Oversight: Oversee the maintenance and qualification of laboratory equipment and instrumentation in both GMP and non-GMP environments

Audit Support: Support internal and external quality audits and maintain the laboratory state of permanent inspection readiness

Requirements:

M.S. with 5-7 years of experience or B.S. with 7-10 years of experience

Must have Metrology expertise: Extensive experience in metrology, including a deep understanding of measurement principles and methodologies. Ability to interpret complex data and apply it to improve project outcomes

Must have experience in instrument Computer System Validation

Must have experience supporting internal and external quality audits within a GMP environment

Understanding of GMP policies and procedures

Experience with pharmaceutical compliance, including change management and deviation management

Leadership in Project Settings: Proven ability to lead and manage projects independently within a regulated environment, with a focus on delivering results through strategic delegation

A strong team player with the ability to work both independently and cross-functionally to deliver on complex objectives

Proven track record of strong technical and innovative problem solving

Desire and ability to learn new concepts outside of core expertise and training

Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills

PMP certification preferred

On-site requirement: This role requires a full-time presence (5 days/week) at the West Point (North Wales), PA site.

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$87,780—$136,225 USD

Benefits

Why Choose Verista?

High growth potential and fast-paced organization with a people-focused culture

Competitive pay plus performance-based incentive programs

Company-paid Life, Short-Term, and Long-Term Disability Insurance.

Medical, Dental & Vision insurances

FSA, DCARE, Commuter Benefits

Supplemental Life, Hospital, Critical Illness and Legal Insurance

Health Savings Account

401(k) Retirement Plan (Employer Matching benefit)

Paid Time Off (Rollover Option) and Holidays

As Needed Sick Time

Tuition Reimbursement

Team Social Activities (We have fun!)

Employee Recognition

Employee Referral Program

Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com

Full-time

Hybrid remote