Pharmaceutical Automation Specialist Job at Randstad (Leiden)

Pharmaceutical Automation Specialist

We are seeking an experienced Automation Specialist with a strong affinity for a...

Location

Netherlands , Leiden

Salary:

3502.00 EUR / Month

Randstad

Expiration Date

February 09, 2027

Requirements

Bachelor or Master degree in Life Sciences, Applied Physics, Chemistry or in other such position
Ability to think critically and resolve issues
Excellent understanding of Excel-based precise formulas
Experience with (Computer) System Validation in an GXP environment
Proven experience in automation, quality control or related fields
Skilled at planning, prioritizing tasks, and thriving in a fast-paced setting
Good team player, also able to work independently
You are able to take actions in absence of specific instructions
You can read and write protocols/reports, business correspondence and procedures

Job Responsibility

Lead technical implementation of new laboratory systems in collaboration with cross functional teams
Implement and maintain SDMS solutions and drive opportunities for paperless workflows
Create and maintain administrator, technical installation, and maintenance procedures
Own data integrity practices, including backup strategies and (disaster) recovery planning
Provide timely support and troubleshooting for computerized system issues
Ensure equipment implementations meet 21 CFR Part 11 compliance requirements
Perform software validation and deliver validated methods to labs to enable new testing approaches for new products
Support and troubleshoot day to day challenges as part of the support team

What we offer

Free public transportation coverage
A team with a great atmosphere
Develop yourself internally with L&D opportunities
Renowned international and innovative workplace
An end-of-year bonus
36 holiday days per year (based on full-time employment)
Unlimited access to free online training via GoodHabitz

Fulltime

Empower Automation Specialist

Do you have a passion for combining analytical methodologies with cutting-edge a...

Location

Netherlands , Leiden

Salary:

3502.00 EUR / Month

Randstad

Expiration Date

April 07, 2027

Requirements

You hold a Bachelor's degree (HBO) in Life Sciences, Computer Science, or possess equivalent experience in a similar role
You have a minimum of 2 years of experience in the pharmaceutical industry with dedicated GMP and automation responsibilities
You have hands-on experience in software development and validation
previous laboratory experience or Computer System Validation (CSV) is a major plus
You possess demonstrable experience with Empower in a GxP environment, preferably including custom fields
You have excellent written and verbal English communication skills (Dutch is a nice-to-have)
You are familiar with, or eager to work with, systems such as SoftMax Pro, SDMS, Deskman, LIMS, 32 Karat, Comet, GAMP 5, 21 CFR Part 11, or Lean/Six Sigma methodologies.

Job Responsibility

Leading the technical implementation of new Empower projects for analytical instruments (ranging from HPLCs and UPLCs to PA800s) alongside cross-functional teams
Implementing and maintaining Empower solutions while actively identifying opportunities to switch to paperless workflows
Creating and maintaining administrative, technical installation, and maintenance procedures
Taking full ownership of data integrity practices, including backup strategies and disaster recovery planning
Providing timely support, software validation, and troubleshooting for computerized system challenges as part of the core support team
Delivering validated methods to laboratories to enable innovative testing approaches for new products
Participating in laboratory systems initiatives and projects in close cooperation with our global organization.

What we offer

Salary starting at € 3502(exp. based)
Year contract with chance of extension
Free public transport(NS business card)
Innovative and international work environment
Learning & Development opportunities
36 vacation days a year!
End-of-year bonus
Unlimited access to free online training courses
NS Business Card for all your travel

Fulltime

Automation Controls Specialist

We're building a world of health around every individual — shaping a more connec...

Location

United States , Mount Prospect

Salary:

46988.00 - 112200.00 USD / Year

CVS Health

Expiration Date

July 01, 2026

Requirements

Experience maintaining/troubleshooting material handling systems, particularly in a pharmacy setting
Ability to identify/develop engineering solutions to repetitive failures and other problems that adversely affect pharmacy operations
Ability to work with engineering and operations management to analyze automation-driven systems
Ability to analyze engineering-design concepts and proposals for new automation equipment, processes, utilities, facilities, controls, and safety/security systems
Ability to review supplier documentation and drawings, proposing design modifications to improve performance within cost and scheduling constraints
Ability to develop criteria for and evaluation of equipment and suppliers
Willingness to observe and/or conduct tests at supplier and pharmacy locations to evaluate equipment construction, installation, and behavior vs. requirements
Willingness to participate in a collaborative vendor evaluation/selection process for new automation equipment/processes
Willingness to train staff on new automation equipment and new features on existing automation equipment
Regular and predictable attendance

Job Responsibility

Troubleshooting, diagnosis, and short-term resolution of issues that negatively affect pharmacy automation performance
Development/Implementation of long-term solutions for ongoing automation Issues, via the use of our Engineering Change Control Process (ECCR)
Provide guidance, oversight, and implementation support for new vendor-provided automation projects
Create documentation (e.g. Manuals, SOPs, Test Plans, Training Guides, etc.) to help support the ongoing knowledge/maintenance of the automation equipment
Provide training on new automation equipment and new features on existing automation equipment to pharmacy personnel

What we offer

Medical, dental, and vision coverage
Paid time off
Retirement savings options
Wellness programs

Fulltime

!

Csv Specialist / Csv Consultant - Mes Validation

Location

India , Hyderabad

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

5+ years of experience in Computer System Validation (CSV)
3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments
3+ years of hands-on experience with MES validation and GxP validation lifecycle
Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations
Experience in validation document preparation, review, execution, and approval workflows
Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams
Strong documentation discipline and attention to detail

Job Responsibility

Validation Plan and Validation Risk Assessment
Requirement Traceability Matrix
IQ, OQ, and PQ protocols
Executed test scripts with objective evidence
Deviation, defect, and issue logs with closure evidence
Validation Summary Report
Approved validation package supporting MES go-live readiness

Fulltime

CSV Specialist / CSV Consultant - MES Validation

We are looking for experienced CSV resources to support a Manufacturing Executio...

Location

India , Hyderabad

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

5+ years of experience in Computer System Validation (CSV)
3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments
3+ years of hands-on experience with MES validation and GxP validation lifecycle
Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations
Experience in validation document preparation, review, execution, and approval workflows
Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams
Strong documentation discipline and attention to detail

Job Responsibility

Support validation planning, impact assessment, risk assessment, and validation strategy for the MES scope
Prepare and review validation documents such as Validation Plan, URS, FRS, DS, RTM, IQ, OQ, PQ, and Validation Summary Report
Prepare, review, and execute validation test scripts with objective evidence as per approved procedures
Log, track, investigate, and support closure of deviations, defects, and validation observations
Validate MES workflows, master data, recipes, electronic batch records, equipment integration, interfaces, and user roles
Ensure alignment with GxP, 21 CFR Part 11, EU Annex 11, ALCOA+, data integrity, and internal quality standards
Maintain end-to-end traceability from requirements to testing and final validation closure
Work closely with MES functional team, technical team, QA, manufacturing SMEs, automation, and business users
Ensure validation deliverables are complete, controlled, and inspection-ready

Fulltime

Specialist SAP Architect, ATTP

In this vital role, you will be a thought leader who helps to drive Amgen’s digi...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master’s degree in computer science or STEM majors and 4 to 6 years of SAP Advanced Track and Trace for Pharmaceuticals (ATTP) and WM/EWM/SRM OR Bachelor’s degree in computer science or STEM majors and 6 to 8 years of SAP Advanced Track and Trace for Pharmaceuticals (ATTP) and WM/EWM/SRM OR Diploma in computer science or STEM majors and 10 to 12 years of IT or years of SAP Advanced Track and Trace for Pharmaceuticals (ATTP) and WM/EWM/SRM
Strong hands-on experience in configuring and customizing SAP ATTP with S/4HANA WM/EWM and MM. with a minimum of 1-2 end to end S/4 EWM and/or ATTP implementations
Hands-on SAP WM/SRM (Stock Room Management) and EWM experience, with proven expertise in solution design and configuration
Good understanding of SAP supply chain processes and in particular serialization, warehouse management, packaging operations with ATTP, Tracelink or SAP Information and Collaboration Hub (ICH)
Should have a deep knowledge of warehouse management, materials management and integration with the other modules, such as PP, QM, and SD. Knowledge of EWM is also preferred
Understanding of global serialization regulations and experience installing, configuring, deploying, documenting and testing systems to meet specific business requirements
Strong understanding of pharmaceutical serialization processes and global compliance frameworks (EU FMD, DSCSA, Russia, Brazil, etc.)
Experience working with SAP ICH is a plus
Familiarity with S/4HANA environments and upgrade/migration projects
Ability to test Function Module, BAPIs and knowledge on ABAP Debugging

Job Responsibility

Design and implementation of SAP ATTP solutions aligned with pharmaceutical serialization and regulatory compliance requirements (e.g., DSCSA, EU FMD, various country market regulations)
Architect, design, and optimize SAP EWM/WM solutions across Amgen’s global manufacturing, packaging, and distribution network
Work as part of a global SAP WM/SRM/EWM expert team, providing coverage, technical leadership, and proactive support across multiple sites and time zones
Define solution architecture, integration points, and data flows between SAP ATTP, SAP ECC/S4HANA (MM, PTS, PP, WM, QM), external contract packaging operations, internal manufacturing systems, external warehouse and automation systems such as ASRS, conveyor systems, MES
Work closely with business process owners to gather requirements, translate them into system specifications, and ensure alignment with business objectives
Drive solution delivery across multiple deployment phases including blueprinting, configuration, testing, and go-live support
Oversee system validation, serialization data management, and E2E integration testing across Logistics Service providers, contract manufacturing organizations (CMOs) and other supply chain partners
Provide technical leadership to internal and external implementation teams, ensuring solution scalability and performance
Support continuous improvement initiatives and roadmap planning for serialization and supply chain traceability systems
Identify and resolve data discrepancies between ERP, ATTP and EWM/WM (e.g., mismatched deliveries, open tasks, HU inconsistencies, or stock variances, serialization data) through proactive monitoring and corrective strategies

Senior Quality Validation Specialist

Leading Global Pharmaceutical Multinational (MNC) is seeking a high-caliber Seni...

Location

Singapore , Singapore

Salary:

7000.00 - 9500.00 SGD / Month

Randstad

Expiration Date

July 19, 2026

Requirements

Minimum of 5 years of robust experience in a highly regulated pharmaceutical or biopharmaceutical manufacturing environment
At least 3 years of dedicated track record in successfully delivering validated laboratory systems qualifications
Strong hands-on experience and structural understanding of automated systems and computerized system validation (CSV) frameworks supporting lab or plant operations
Proven ability to work independently, influence cross-functional teams, and deliver results under tight project schedules
Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, and/or laboratory operations
A Bachelor’s Degree or Diploma in a relevant technical or scientific discipline

Job Responsibility

Lead and oversee the preparation, review, and execution of validation lifecycle documentation (URS, DQ, IQ, OQ, PQ) for complex automated and computerized systems
Provide deep, hands-on expertise in the qualification of automated systems supporting manufacturing (e.g., PLC/SCADA, MES) and/or advanced laboratory operations (e.g., LIMS, Empower, instrument software integrations)
Ensure all validation activities strictly comply with global Good Manufacturing Practices (GMP), GAMP 5 methodologies, and stringent Data Integrity standards (21 CFR Part 11 / ALCOA+ principles)
Partner closely with Automation, IT, Quality Control, and QA teams to manage project timelines. Drive risk assessments (FMEA) and proactively mitigate validation delays
Provide senior-level oversight for validation deviations. Lead thorough root-cause investigations and implement robust Corrective and Preventive Actions (CAPA)

What we offer

SGD 250 Monthly Transport Allowance

Fulltime

Quality Validation Specialist

The new employee, reporting directly to the Quality Validation Coordinator, will...

Location

Italy , Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Master’s degree in industrial chemistry, Pharmaceutical Chemistry and Technology (CTF), Chemistry, Chemical Engineering, Biomedical Engineering or Automation Engineering
Knowledge of the main ALCOA+ principles
Knowledge of the key Data Integrity guidelines
Strong interpersonal and communication skills
Result‑oriented mindset with strong problem‑solving skills
Good organizational skills
Good knowledge of GMP Quality Systems
Minimum of 5 years working within pharmaceutical manufacturing
Strong command of the English & Italian languages, technical writing skills are a must

Job Responsibility

Ensure the implementation and ongoing maintenance of ALCOA / ALCOA+ principles throughout the entire GMP data lifecycle
Support and/or perform Data Integrity Risk Assessments (DIRA) on processes, equipment, and computerized systems
Evaluate and approve data governance controls, including access management, audit trails, backup, archiving, and data lifecycle management
Manage data integrity deviations and incidents, including the definition and follow‑up of CAPAs
Support regulatory inspections and audits as Data Integrity Subject Matter Expert (SME)
Perform critical QA review and approval of equipment qualification documentation, including: User Requirement Specification (URS) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Qualification reports and requirements traceability Periodic requalification activities
Ensure documentation compliance with GMP requirements, Annex 11, and GAMP 5
Assess GMP impacts of change controls related to equipment and systems
Participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
Collaborate with other Site Departments in order to achieve the goal of the company’s projects

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Fulltime

Select Country

Pharmaceutical Automation Specialist

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?

Pharmaceutical Automation Specialist

Pharmaceutical Automation Specialist

Empower Automation Specialist

Automation Controls Specialist

Csv Specialist / Csv Consultant - Mes Validation

CSV Specialist / CSV Consultant - MES Validation

Specialist SAP Architect, ATTP

Senior Quality Validation Specialist

Quality Validation Specialist

Our AI answers in your language