BioTalent
Location:
Hybrid – Remote with periodic travel to client site Start Date:
Within 2–4 weeks Hours:
Full-time (40 hrs/week) Rate:
Competitive (W2 or C2C + approved expenses) Position Overview
Our client, a global biopharmaceutical manufacturer, is seeking a
Lab / LIMS Engineer
to support implementation, integration, and lifecycle management of laboratory systems within a GMP environment. This role will sit within the Digital / Automation function and act as the
technical owner
for LIMS and connected lab applications — enabling data integrity, automation connectivity, and paperless laboratory operations. The successful candidate will work closely with Quality, IT, and Manufacturing to design and deliver scalable, compliant laboratory informatics solutions supporting QC, analytical development, and tech transfer activities. Key Responsibilities
Serve as the
technical lead
for LIMS configuration, administration, and integration with analytical instruments, LES/ELN, and other lab systems. Design, configure, and maintain
LIMS master data , workflows, specifications, methods, and stability study templates. Manage
system interfaces and data exchange
(e.g., Empower, Chromeleon, SAP, PI, LES, ELN, CDS). Partner with IT and QA on
CSV/CSA validation activities , authoring and reviewing URS/FRS, risk assessments, test scripts, and trace matrices. Support deployment, upgrades, and change control for LIMS and lab systems, ensuring
21 CFR Part 11
and
Annex 11
compliance. Provide
technical troubleshooting
and root-cause analysis for lab system issues. Collaborate with business stakeholders to streamline workflows and enable digital transformation within the QC labs. Support
audit and inspection readiness , providing objective evidence for system compliance. Train end users and develop supporting SOPs, WIs, and documentation as required. Required Experience
7+ years
of experience supporting and configuring LIMS systems in the
pharmaceutical/biotech industry . Hands-on experience with at least one of:
LabVantage, LabWare, SampleManager, MODA, or STARLIMS . Demonstrated understanding of
GAMP 5 ,
21 CFR Part 11 ,
Annex 11 , and
ALCOA+
data integrity principles. Experience integrating LIMS with
instrumentation, Empower/Chromeleon , and enterprise systems (e.g.,
SAP, PI, MES, ELN ). Proven ability to deliver LIMS configuration, validation, and change management documentation in GxP environments. Excellent stakeholder management — able to communicate effectively with QC, QA, IT, and Automation teams. Preferred Skills
Exposure to
cloud-hosted LIMS environments
and SaaS supplier qualification. Experience with
Kneat, ValGenesis, or Veeva Vault
for validation lifecycle management. Background in
automation/data integration
(OSIsoft PI, OPC, or middleware tools). Understanding of
Lab Automation ,
LES/ELN , or
robotic lab systems . Technical degree in
Computer Science, Engineering, Chemistry, or related discipline . Seniority level
Mid-Senior level Employment type
Contract Job function
Engineering and Science Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at BioTalent by 2x
#J-18808-Ljbffr
Hybrid – Remote with periodic travel to client site Start Date:
Within 2–4 weeks Hours:
Full-time (40 hrs/week) Rate:
Competitive (W2 or C2C + approved expenses) Position Overview
Our client, a global biopharmaceutical manufacturer, is seeking a
Lab / LIMS Engineer
to support implementation, integration, and lifecycle management of laboratory systems within a GMP environment. This role will sit within the Digital / Automation function and act as the
technical owner
for LIMS and connected lab applications — enabling data integrity, automation connectivity, and paperless laboratory operations. The successful candidate will work closely with Quality, IT, and Manufacturing to design and deliver scalable, compliant laboratory informatics solutions supporting QC, analytical development, and tech transfer activities. Key Responsibilities
Serve as the
technical lead
for LIMS configuration, administration, and integration with analytical instruments, LES/ELN, and other lab systems. Design, configure, and maintain
LIMS master data , workflows, specifications, methods, and stability study templates. Manage
system interfaces and data exchange
(e.g., Empower, Chromeleon, SAP, PI, LES, ELN, CDS). Partner with IT and QA on
CSV/CSA validation activities , authoring and reviewing URS/FRS, risk assessments, test scripts, and trace matrices. Support deployment, upgrades, and change control for LIMS and lab systems, ensuring
21 CFR Part 11
and
Annex 11
compliance. Provide
technical troubleshooting
and root-cause analysis for lab system issues. Collaborate with business stakeholders to streamline workflows and enable digital transformation within the QC labs. Support
audit and inspection readiness , providing objective evidence for system compliance. Train end users and develop supporting SOPs, WIs, and documentation as required. Required Experience
7+ years
of experience supporting and configuring LIMS systems in the
pharmaceutical/biotech industry . Hands-on experience with at least one of:
LabVantage, LabWare, SampleManager, MODA, or STARLIMS . Demonstrated understanding of
GAMP 5 ,
21 CFR Part 11 ,
Annex 11 , and
ALCOA+
data integrity principles. Experience integrating LIMS with
instrumentation, Empower/Chromeleon , and enterprise systems (e.g.,
SAP, PI, MES, ELN ). Proven ability to deliver LIMS configuration, validation, and change management documentation in GxP environments. Excellent stakeholder management — able to communicate effectively with QC, QA, IT, and Automation teams. Preferred Skills
Exposure to
cloud-hosted LIMS environments
and SaaS supplier qualification. Experience with
Kneat, ValGenesis, or Veeva Vault
for validation lifecycle management. Background in
automation/data integration
(OSIsoft PI, OPC, or middleware tools). Understanding of
Lab Automation ,
LES/ELN , or
robotic lab systems . Technical degree in
Computer Science, Engineering, Chemistry, or related discipline . Seniority level
Mid-Senior level Employment type
Contract Job function
Engineering and Science Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at BioTalent by 2x
#J-18808-Ljbffr