Validation Engineer, QC

5 days ago

Framingham, United States Grove Technical Resources, INC Full time

Job Title: Senior Validation Engineer, QC & Analytical Software

Duration: 6 months with possibility of extension

Location: Hybrid – Candidates need to be commutable to Framingham, MA up to 3x per week. This role will require occasional travel to Charlton, MA to validate equipment software at their other facility.


C2C Workable for this position.


Additional Info (optional):

They have a lot of equipment across their two sites that needs their software to be upgraded and validated.



Job Description:

Our client is a small biotechnology company based in Framingham, MA that provides development, manufacturing and services. Primarily focusing on upstream manufacturing of the recombinant proteins.


Responsibilities:

Lead the upgrade, validation, and implementation of QC software systems, including but not limited to LIMS, Trackwise, Optel, Asset Management, and IQVIA.

Ensure the compliance of all systems and processes with applicable regulatory standards (GxP, FDA, etc.).

Manage and support data loggers, including calibration, maintenance, and troubleshooting.

Provide technical expertise in Computer System Validation (CSV) and execute validation protocols, test scripts, and reports.

Collaborate with cross-functional teams to implement QC software solutions that meet business and regulatory requirements.

Identify and resolve issues related to QC instrumentation, software, and system performance.

Maintain detailed documentation of system validations, configurations, and operational procedures.

Support project implementations and system integrations across QC and operational teams.


Required Skillset Qualifications:

5+ years of experience in QC instrumentation, software, and systems, with expertise in LIMS, Trackwise, Optel, Asset Management, IQVIA, or similar platforms.

Strong knowledge of Computer System Validation (CSV) processes, QC software upgrades, and regulatory compliance requirements.

Proven ability to troubleshoot and resolve technical issues related to QC systems and instrumentation.

Experience working in a regulated environment (e.g., GMP, FDA, ISO) is required.

Strong interpersonal and communication skills to effectively collaborate with cross-functional teams.

Must be able to travel to Framingham, MA and occasionally to Charlton, MA, to support equipment-related tasks.

Experience with any of the following instrumentation or software is highly desired:

SD Tanks

TruScan ALZ

TruScan EQP

Biomek i5

TCU Framingham

Refrigerator New

Agilent GC 7890

Coswin

Slingshot - Server

Commissioning - Glasswasher and Dryer

QC Micro autoclave

Genesys Spectrophotometer

Small Parts / (4) UF DF

Temp Mapping

TCU

Endoscan

ENNOV

Smoke Study MFG

Genesys Spectrophotometer

TrackWise

Endoscan

TruScan ALZ

TruScan EQP

Biomek i5

Agilent GC 7890

Commissioning - Glasswasher and Dryer

QC Micro autoclave

LIMS

Genesys Spectrophotometer

ENNOV

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