FDA regulated environment jobs

Pharmaceutical Operator - FFEx AP

Novo Nordisk A/S · Posted Nov 10, 2026

Open

Clayton, North Carolina, United States
2+ years

Apply with RefersoAI Apply on careers page

Pharmaceutical Operator - FFEx AP

Novo Nordisk A/S · Posted Nov 10, 2026

Open

Clayton, North Carolina, United States
2+ years

Apply with RefersoAI Apply on careers page

Logistics Specialist

Illumina · Posted Nov 6, 2026

Open

San Diego, California, United States
$28–$41 per hour
3–5 years

Apply with RefersoAI Apply on careers page

Support daily transportation and logistics activities, coordinate freight and inventory processes, ensure compliance with quality regulations, and collaborate with cross‑functional teams.

Compensation

The estimated base hourly range for the Logistics Specialist role based in the United States of America is: $27.50 - $41.25. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long‑term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package.

Responsibilities

Track and trace from suppliers and for customer deliveries.
Coordinate RMA & Scrap process in collaboration with our customer service team.
Freight auditing & processing claims through NVision.
Develop policies, guidelines and procedures; train and implement them.
Ensure compliance with all quality regulations and established standard procedures.

Requirements

College degree preferred

Skills

ERP SAP Microsoft Office Standard Operating Procedures (SOPs)Work Instructions (WIs)

Sr Engineer - Process Development

Illumina · Posted Nov 6, 2026

Open

San Diego, California, United States
Senior
$98K–$148K per year
5+ years

Apply with RefersoAI Apply on careers page

Process Engineer responsible for developing and deploying oligonucleotide manufacturing processes within Illumina’s Reagent Development team.

Compensation

The estimated base salary range for the Sr Engineer - Process Development role based in the United States of America is: $98,400 - $147,600.

Responsibilities

Execute feasibility and development oligonucleotide builds to support project timelines
Ideate and create manufacturing processes and define technical requirements for new production equipment
Author procedures and instructions for new manufacturing processes and train production operators in a GMP environment
Troubleshoot new product and manufacturing process issues related to yield, quality and throughput
Construct and execute controlled experiments including DOE’s to optimize processes and scale

Requirements

Bachelor’s degree
Master’s degree
PhD
Nice to have: high volume production
Nice to have: product development processes

Skills

oligonucleotide synthesis cleavage/deprotection purification desalting

Maintenance Planner Scheduler

6084-Janssen Research & Development Legal Entity · Posted Nov 6, 2026

Open

Wilson, North Carolina, United States
On-site
Full-time · Mid
5+ years

Apply with RefersoAI Apply on careers page

The Maintenance Planner/Scheduler is responsible for planning, scheduling, and coordinating maintenance work with multifunctional teams to maximize asset performance within the manufacturing environment.

Responsibilities

Using the site CMMS, owns the maintenance schedule that provides process level overview of manufacturing activities with a monthly horizon.
Prepares and communicates detailed maintenance schedule one week in advance, coordinating maintenance and manufacturing personnel and equipment.
Works in partnership with MRO to ensure availability of stock and non-stock supplies and parts.
Ensure jobs are walked down and detailed plans are drafted.
Ensure parts are identified and ordered before work is scheduled.

Requirements

recognized trade qualification
Diploma
Degree in Engineering
equivalent qualification in a relevant technical discipline
Nice to have: Scientific or technical qualification in mechanical, electrical, instrumentation & controls, utilities engineering

Skills

Maintenance utilities experience Technical background in manufacturing requirements engineering elements

Consultant - Business Consulting Risk - TMT - CNS - RISK - DIGITAL RISK

EY · Posted Nov 7, 2026

Open

Mumbai, Maharashtra, India
On-site
Full-time · Mid
2–13 years

Apply with RefersoAI Apply on careers page

Consultant role within TMT Business Consulting Risk, focusing on Digital Risk and Computer System Validation (CSV) for Life Sciences clients.

Responsibilities

Perform assessments of computer systems and processes for Life Sciences clients
Create/ review CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs, and validation summary reports
Provide guidance and oversight of validation activities for projects involving GxP relevant computer systems
Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle
Review and approve computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables

Requirements

Bachelor of Technology in Computer Science
B pharmacy
Bachelor of Computer Applications
Nice to have: HPALM
Nice to have: Azure DevOps (ADO)

Skills

Computer System Validation Quality and Compliance Enterprise Applications

QC Analytical Chemist

bioMérieux · Posted Nov 5, 2026

Open

Hazelwood, Missouri, United States
$59K–$88K per year
3+ years

Apply with RefersoAI Apply on careers page

Responsible for quality, safety, and compliance of materials and products used in commercial medical device diagnostic product manufacture; performs analytical testing in a cGMP laboratory.

Compensation

The estimated salary range for this role is between $58,700 and $88,000.

Responsibilities

Perform testing of raw materials, reference standards, in-process materials, finished products, and stability samples.
Operate, troubleshoot, and maintain HPLC, IC, FTIR, UV-Vis, conductivity, pH, titration systems, balances, and related equipment.
Review data for GDP and ALCOA+ compliance.
Support OOS, OOT, deviations, CAPA, nonconforming-material investigations, root cause analysis, method verification, validation, transfers, qualification, calibration, and preventive maintenance.
Partner cross-functionally on disposition and production schedules.

Requirements

Bachelor's degree in Chemistry, Analytical Chemistry, Biology, Biochemistry, or related scientific discipline

Skills

HPLC FTIR UV-Vis IC

EXPANSION Validation Specialist

Piramal Pharma Ltd · Posted Nov 5, 2026

Open

Lexington, Kentucky, United States
On-site
Associate
2+ years

Apply with RefersoAI Apply on careers page

The Validation Specialist executes validation and qualification protocols of manufacturing, packaging, laboratory, utility systems and other equipment, in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.

Responsibilities

Write, schedule, plan, manage and execute validation and qualification protocols
Act as technical interface between the company and 3rd parties for discussions surrounding the on-site validation activities
Coordinate and interface with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance groups to ensure successful project execution
Lead qualification activities and timelines for equipment purchased for manufacturing purposes
Coordinate order timelines and equipment requirements with Technical Services group

Requirements

Bachelor’s Degree in the physical or biological sciences or engineering
Nice to have: Sterile manufacturing of injectables

Skills

cGMP FDA regulated environment Technical writing root cause analysis

Pharmaceutical Operator - FFEx AP

Pharmaceutical Operator - FFEx AP

Compensation

Responsibilities

Requirements

Skills

Benefits

Logistics Specialist

Compensation

Responsibilities

Requirements

Skills

Sr Engineer - Process Development

Compensation

Responsibilities

Requirements

Skills

Maintenance Planner Scheduler

Responsibilities

Requirements

Skills

Consultant - Business Consulting Risk - TMT - CNS - RISK - DIGITAL RISK

Responsibilities

Requirements

Skills

QC Analytical Chemist

Compensation

Responsibilities

Requirements

Skills

EXPANSION Validation Specialist

Responsibilities

Requirements

Skills

Benefits

Benefits

Benefits

Benefits