United Pharma
Responsibilities
Develop, execute, and document validation strategies in compliance with
FDA, EMA, and ICH Q7–Q10
guidelines.
Lead or support
Process Validation (PV)
and
Process Performance Qualification (PPQ)
activities, including protocol development, approval, execution, and reporting.
Perform
commissioning and qualification (C&Q)
of GMP equipment, utilities, and facility systems in accordance with SOPs and regulatory requirements.
Conduct
risk assessments and gap analyses
on manufacturing processes and equipment; recommend appropriate validation approaches.
Support
equipment lifecycle management , including periodic reviews to ensure continued qualification and compliance.
Maintain accurate
equipment master data , technical specifications, and documentation for audit readiness.
Manage and execute
change control
activities with thorough impact assessment and documentation.
Collaborate closely with
Manufacturing, QA, QC, and Process Development
teams to ensure seamless execution of validation activities.
Author, review, and maintain
SOPs, protocols, and validation reports
reflecting current process conditions and regulatory expectations.
Ensure alignment between
process requirements, equipment qualification, and control strategies
throughout the validation lifecycle.
Execute validation activities on the
manufacturing floor , including equipment setup, process monitoring, sampling, and in-process data collection in GMP cleanroom environments.
Coordinate and perform
sampling activities
using proper aseptic techniques, labeling, chain‑of‑custody, and timely transfer to QC or analytical labs.
Prepare and process samples (e.g., filtration, incubation, aliquoting) while maintaining strict data integrity and documentation standards.
Support
recipe authoring, data trending, and control strategy development
for manufacturing and automation systems, including batch records.
Provide training and technical guidance to operations and cross‑functional teams during validation efforts.
Support intermittent
on‑call or off‑shift work
as required for validation execution.
Qualifications & Skills
Bachelor’s degree or higher in
Chemical, Mechanical, Biomedical, or related Engineering discipline .
1‑3 years
of experience in
biopharma process or validation engineering , preferably in GMP biologics manufacturing.
Strong hands‑on experience with
process validation and equipment qualification .
Proficiency in
risk‑based validation methodologies
(e.g., FMEA).
In‑depth knowledge of
FDA/EMA cGMP
regulations and
ICH Q7‑Q10
guidelines.
Experience with
MES, process automation systems, and LIMS .
Hands‑on laboratory experience, including
pipetting, aliquoting, labeling, and sample handling .
Excellent
technical writing, communication, and collaboration
skills.
Ability to work effectively in a
fast‑paced, cross‑functional environment .
Willingness and ability to work in
classified cleanroom environments
and comply with gowning requirements.
Seniority Level Associate
Employment Type Contract
Industry Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
Location Raritan, NJ
Salary $75,972.00 – $99,713.00
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Develop, execute, and document validation strategies in compliance with
FDA, EMA, and ICH Q7–Q10
guidelines.
Lead or support
Process Validation (PV)
and
Process Performance Qualification (PPQ)
activities, including protocol development, approval, execution, and reporting.
Perform
commissioning and qualification (C&Q)
of GMP equipment, utilities, and facility systems in accordance with SOPs and regulatory requirements.
Conduct
risk assessments and gap analyses
on manufacturing processes and equipment; recommend appropriate validation approaches.
Support
equipment lifecycle management , including periodic reviews to ensure continued qualification and compliance.
Maintain accurate
equipment master data , technical specifications, and documentation for audit readiness.
Manage and execute
change control
activities with thorough impact assessment and documentation.
Collaborate closely with
Manufacturing, QA, QC, and Process Development
teams to ensure seamless execution of validation activities.
Author, review, and maintain
SOPs, protocols, and validation reports
reflecting current process conditions and regulatory expectations.
Ensure alignment between
process requirements, equipment qualification, and control strategies
throughout the validation lifecycle.
Execute validation activities on the
manufacturing floor , including equipment setup, process monitoring, sampling, and in-process data collection in GMP cleanroom environments.
Coordinate and perform
sampling activities
using proper aseptic techniques, labeling, chain‑of‑custody, and timely transfer to QC or analytical labs.
Prepare and process samples (e.g., filtration, incubation, aliquoting) while maintaining strict data integrity and documentation standards.
Support
recipe authoring, data trending, and control strategy development
for manufacturing and automation systems, including batch records.
Provide training and technical guidance to operations and cross‑functional teams during validation efforts.
Support intermittent
on‑call or off‑shift work
as required for validation execution.
Qualifications & Skills
Bachelor’s degree or higher in
Chemical, Mechanical, Biomedical, or related Engineering discipline .
1‑3 years
of experience in
biopharma process or validation engineering , preferably in GMP biologics manufacturing.
Strong hands‑on experience with
process validation and equipment qualification .
Proficiency in
risk‑based validation methodologies
(e.g., FMEA).
In‑depth knowledge of
FDA/EMA cGMP
regulations and
ICH Q7‑Q10
guidelines.
Experience with
MES, process automation systems, and LIMS .
Hands‑on laboratory experience, including
pipetting, aliquoting, labeling, and sample handling .
Excellent
technical writing, communication, and collaboration
skills.
Ability to work effectively in a
fast‑paced, cross‑functional environment .
Willingness and ability to work in
classified cleanroom environments
and comply with gowning requirements.
Seniority Level Associate
Employment Type Contract
Industry Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
Location Raritan, NJ
Salary $75,972.00 – $99,713.00
#J-18808-Ljbffr