5697 - Sr. Systems Validation Specialist / Lead Validation Engineer

ZipRecruiter; North Wales (Montgomery County); On-site; USD 87,000 - 137,000; Full time

Job summary

A leading company in the life sciences sector is seeking a Senior Systems Validation Specialist to drive quality and operational excellence across its labs. The successful candidate will manage projects, mentor junior staff, and ensure compliance within GMP environments, contributing to the development of life-changing medicines.

Benefits

Competitive pay plus performance-based incentives

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

Medical, Dental & Vision insurances

401(k) Retirement Plan (Employer Matching)

Tuition Reimbursement

Paid Time Off (Rollover Option)

Team Social Activities

Paid Parental Leave

Qualifications

• 5-7 years of experience with M.S. or 7-10 years with B.S.
• Experience in instrument Computer System Validation.
• Understanding of GMP policies and procedures.

Responsibilities

• Develop and manage project plans for metrology and validation tasks.
• Mentor and coach junior scientists.
• Oversee maintenance and qualification of laboratory equipment.

Skills

Metrology expertise

Project management

Leadership

Communication skills

Problem solving

Education

M.S. in relevant field

B.S. in relevant field

Job description

Job DescriptionJob 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

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.

(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 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