Browse by job sector

Technical Services Specialist

  1. NI & Ireland
County Westmeath
  1. Contract
Competitive
  1. Life Sciences
07-04-2021
26352- ML

This vacancy has now expired

12 month contract - County Westmeath - Technical Services Specialist

Our leading biopharmaceutical client offers an invaluable experience to work on their state of the art fill-finish facility.

Located in the picturesque Irish midlands, the area oozes culture and tranquillity in a town where their infamous folk music at the local a focal point of entertainment, making this one of a kind facility one of the leading places to work. 

Essential Duties and Responsibilities for this Technical Services Specialist role include, but are not limited to, the following:
  • Provide significant technical expertise to support all aspects of the mammalian bulk drug substance cell culture and purification manufacturing at the biologics Facility
  • Process SME to support commissioning, automation and manufacturing operation teams.
  • Support technology transfers of new products into the Facility
  • Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables.
  • To author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
  • To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting.
  • Partner with Operations to support protocol completion, execution and sample reconciliation.
  • To generate documentation reports for technical studies
  • Lead any key process changes using change control management system as required.
  • Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
  • Ensure compliance with site EHS policy, cGMP and other business regulations.
Desirable Experience:
  • Experience in technical services support in the manufacture of mammalian drug substance cell culture and purification and/or process development and/or manufacturing support
  • Experienced in relevant unit operations including vial thaw and scale up, seed train and production bioreactors, harvest, chromatography, UF/DF, viral filtration and inactivation, final formulation and media and buffer preparations.  
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices.
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically in the manufacture of mammalian bulk drug substance operations.
  • Prior experience of single use systems (bioreactors, single use mixers) would be an advantage
  • Ability to present and defend technical aspects of manufacturing operations.
  • Self-motivated, detail orientated enjoys the fast pace environment of startup.
If this sounds like something of interest to you then please apply today!

The candidate must have the rights to work in the location stated in the job advert.

Please note, Quanta part of QCS Staffing does not sponsor Visa applications.

To view Quanta's privacy policy, please visit our website
Save as a job alert
List #1

Similar Jobs

Quality Technician

Salary

€20 - €32 per hour

Location

Carlow

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Permanent

Location

Midlands (Ireland)

Description

Quality Technician - Pharmaceuticals - Carlow, Ireland - 11-Month Contract+  Do you want to be involved with exciting Pharmaceutical projects? When it comes to the development and production

Reference

33441

Expiry Date

01/01/0001

Christopher Hutchinson

Author

Christopher Hutchinson
Christopher Hutchinson

Author

Christopher Hutchinson
Read more
Read more
CMMS Engineer

Salary

Competitive

Location

County Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Dublin

Description

CMMS Engineer - Pharmaceuticals - Dublin - 9-Months  Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives? Our client, a

Reference

33743

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more
Automation Engineer

Salary

Competitive

Location

County Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Dublin

Description

VPE Automation Engineer - Dublin, Ireland - 12-Month Contract  Do you want to work with an exciting company who are an established market leader within their niche field? We have a fantastic

Reference

33582

Expiry Date

01/01/0001

Finn Bannon

Author

Finn Bannon
Finn Bannon

Author

Finn Bannon
Read more
Read more

Insights

Top Life Science Skills for 2024

Top Life Science Skills for 2024
Read more

01/25/2024

Living and Working in Milan

Living and Working in Milan
Read more

11/07/2023

Day In the Life of a Commissioning Engineer

Day in the Life of a Commissioning Engineer

Read more

11/03/2023

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV