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Associate Program Manager - Validation Engineer - 5268

VeristaOnsite

Description


Verista’s 600 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

(ADD) Responsibilities:


Assessment of Digital QC Lab’s SDMS System. Associate Program Manager will assist the Senior Program Manager in:

  • Perform Study on path forward of SDMS within Moderna CMC Quality testing Labs:
  • Driver to implement SDMS
  • Compliance on e-record audit trail, versioning, access control, archival & retrieval
  • Homogeneous Data output format via integration/parsing/upload
  • Security

  • Market and active providers of SDMS

  • Traditional SDMS & vendors
  • Market Majority: NuGenesis
  • LogiLab
  • Integration and Storage
  • Scitara, Zontal, TetraSciense, Benchling, etc.
  • AWS
  • What are other pharma companies & biotechs doing?
  • PROs & CONs on potential options including total cost
  • Will be CFR Gateway kept as part of the original deal from the same LogiLab vendor
  • What will be the Impact to Tech Dev within CMC which is using LogiLab as well
  • Potential hybrid approach covering proprietary binary raw data and readable raw data
  • Outcome: provide recommendation based on assessmentOptions
  • Effort & Resources • Duration
  • Budget
  • Approach

Requirements


  • Demonstrated experience managing Digital Laboratory System implementations

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

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

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.


$59,951-102,705


*Verista is an equal opportunity employer.

Life at Verista

Verista offers transformative compliance, automation, validation and packaging solutions to leaders in the pharmaceutical and life sciences, nutrition and supplements, food and beverage, and manufacturing industries. Verista was launched in 2020 by bringing together three trusted firms: Clarke Solutions, Covex LLC, and Acquire Automation. Verista's customers trust our 350+ experts to deliver consistent, safe, and high-quality results. Verista's consultants bridge the traditional chasm between IT and operations, following repeatable processes that deliver solutions for individual devices, capital equipment, site and enterprise-wide systems, regulatory and sales. Verista, a holding of private equity firm Lightview Capital, is based in Fishers, Indiana, and Wayne, Pennsylvania.
Thrive Here & What We Value1. People-focused culture2. High growth potential and fast-paced organization3. Competitive pay plus performance-based incentive programs4. Company paid medical premiums, Life, ShortTerm, and Long-Term Disability insurances, Dental & Vision insurances, Health Savings Account, 401(k) Retirement Plan (Employer Matching benefit), Paid Time Off (Rollover Option)5. Employee Recognition6. Team Social Activities7. Employee Referral Program8. Paid Maternity, Parental Leave and Bereavement
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