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Sr. Systems Engineer, Quality Systems 

resume-library  |  United States  |  

United Statesnull, null, null
Work Type:
Work Time:
Full Time


Sr. Systems Engineer, Quality Systems

Reporting to the Senior Manager, GxP Quality Computer Systems, the Sr.

Engineer, Quality Systems will support the design, delivery of software

solutions and administration of the Validation Management System and other

quality compliance systems. The role will be accountable for project delivery,

key technical activities such as configuration/customization of system, and

compliance and operational support. Activities will also include cross training

of other digital system.

This is an exciting role to shape new solutions with specialized focus in

expanding functional processes within the Validation Management System. This

role will have a significant impact on transforming manual paper-based

processes and expanding Moderna s Digital footprint.

Here s_What_You ll_Do

* Define functional solutions, determine and perform configuration /

programs and develop data strategy

* Partner with quality systems, facilities & engineering, MS&T and quality

control teams when developing system solutions.

* Lead technical projects focusing on implementing functional solutions and

expanding the capabilities of the Compliance systems

* Performs evaluation and prioritization of system enhancements and

capabilities to ensure efficient usage and maintenance

* Evaluates functional configuration issues and provides advanced support

on issue resolution

* Provide administrator support to operate systems including role

management, access management and data management

* Provide technical design insight within the applications, maintain and

improve data model and integrations between compliance systems other

systems including ERP, LIMS, LMS and MES

* Write business design documents, functional specs, test documentation and


* Develops custom system and process templates to reduce overall validation

cycle times

* Generates standard and custom reports based on business and compliance


Here s_What_You ll_Bring_To_The_Table

* Bachelor s degree in engineering, science, technology or another

relevant academic discipline

* 4-8 years of experience implementing and maintaining technology to

support quality systems in a regulated biotech or Pharma company

* Detailed knowledge of the Validation Lifecycle and Process to support

Computerized Systems, Facilities Utilities, Engineering, Process

Validation and Qualification and Method Validation.

* Excellent interpersonal and communication skills with ability to work

collaboratively within a team of cross functional stakeholders to

influence decisions

* Quality orientated with strong attention toward detail

* Self-directed with effective analytical and problem-solving skills. Must

be able to deliver results on multiple complex assignments simultaneously

in a fast-paced environment

* Understanding of industry technology trends in validation management,

process Qualification quality management, document management and

learning management.

* Experience with Validation Management System (Kneat), Veeva Vaults

(Quality (Docs and eQMS), SAP SuccessFactors Learning Management, Please

Review, or similar technologies

* Expertise with computer systems validation practices (GAMP) and ERES

(21CFR Part 11 and Annex 11) regulations and guidelines.

* API, data report development and systems integration

* Working knowledge of relevant FDA, EU, ICH guidelines and regulations

related to computer system validation and data integrity

* Technical writing skills required

Here s_What_We ll_Bring_To_The_Table

* On-site subsidized cafeteria or catered lunches

* Company-provided iPhone

* Free parking, monthly subway pass or a subsidized commuter rail pass

* Free annual corporate membership to Bluebikes

* Highly competitive healthcare coverage including: medical offered through

BCBS (HMO/PPO), dental, and vision offered through VSP

* Flexible Spending Accounts for medical expenses and dependent care


* 16 weeks of 100% paid parental leave for all new parents

* 16 weeks 100% paid family caregiver leave

* 20 weeks 100% paid medical leave

* Eligible for Moderna Month (one month paid sabbatical after fi

years of service and eligible for additional one month paid sabbatical

every 3 years thereafter)

* Adoption assistance and discounts to local childcare centers, as well as

access to

* 401k (traditional and Roth offered) with 50% match on first 6% deferred.

Match is vested immediately

* A suite of Moderna paid insurance coverage, including: life insurance,

short-term and long-term disability

* Voluntary legal assistance plan

* 15 days vacation and 7 sick days per year, in addition to a

discretionary winter shut down and 11 company paid holidays (includes 2

floating holidays)


Moderna is advancing messenger RNA (mRNA) science to create a new class of

transformative medicines for patients. mRNA medicines are designed to direct

the body s cells to produce intracellular, membrane or secreted proteins th

can have a therapeutic or preventive benefit and have the potential to address

a broad spectrum of diseases. The Company s platform builds on continuous

advances in basic and applied mRNA science, delivery technology and

manufacturing, providing Moderna the capability to pursue in parallel a robust

pipeline of new development candidates. Moderna is developing therapeutics and

vaccines for infectious diseases, immuno-oncology, rare diseases,

cardiovascular diseases, and autoimmune and inflammatory diseases,

independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances

for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the

Defense Advanced Research Projects Agency (DARPA), an agency of the U.S.

Department of Defense, the Biomedical Advanced Research and Development

Authority (BARDA), a division of the Office of the Assistant Secretary for

Preparedness and Response (ASPR) within the U.S. Department of Health and Human

Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI).

Moderna has been ranked in the top ten of Science s list of top biopharma

industry employers for the past five years. To learn more, visit



Deliver on the promise of mRNA science to create a new generation of

transformative medicines for patients.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for

all employees and qualified applicants without regard to a person s race,

color, gender, age, religion, national origin, ancestry, disability, veteran

status, genetic information, sexual orientation or any characteristic protected

under applicable law. Moderna will make reasonable accommodations for qualified

individuals with known disabilities, in accordance with applicable law.