Browse by job sector

Construction Manager

  1. North America, United States
Maryland
  1. Contract
Competitive
  1. CAPEX Projects
33519

This vacancy has now expired

Construction Manager - Pharma - Maryland - 12-Month Contract 

Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for a Construction Manager to help support operations at their Maryland facility.

With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!


Your main tasks will be:
  • Defines the risk-based commissioning and qualification strategy for facilities and utilities equipment and Computerized Systems (CSV) and puts into action from end-to-end.
  • Performs the C&Q of new, upgraded or existing assets incl. all required documentation within a given timeline and budget
  • Writes and executes Impact Assessments, DQ's, IQ's, OQ's as well CSV activities
  • Supports creation of Change Control's, URS's, FMEA's as well as Validation Documents and PQ's
  • Participates in inspections as well as audits and drives investigations, deviations, corrective and preventive actions towards successful and compliant closure
  • Assures compliance with all applicable cGMPs, regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies
  • Provide leadership and act as true expert in the field C&Q
  • Manage strategic partnerships with contractors and vendors
  • Leads and develop associated engineers, technicians or external contributors
 
Qualifications :
  • Degree in Engineering, Science or related discipline.
  • 6-10 years of experience in pharmaceutical plant based or consultancy role
  • A minimum of 5 years' experience in leading commissioning and qualification activities
  • A minimum of 3 years of proven project management experience
  • Previous experience managing C&Q budgets over $5 million preferred
  • Previous experience with international health authority inspections as well as internal and external audits
  • Self-driven and able to set own targets
  • Ability to set priorities under pressure
  • In depth knowledge of current GMP standards and guidelines related to equipment, utilities and facilities commissioning and qualification (e.g. ISO, EN, ICH, FDA, ISPE)
  • Previous experience working in a large matrix-managed environment preferred
  • Previous experience with Trackwise, SAP and Documentum system is preferred.
  • Fluent in English (written and spoken), Spanish language is beneficial
  • Proactive, open teamplayer that recognizes C&Q as a service

If this role is of interest to you, please apply now! 

 #LI-AN1
Save as a job alert
List #1

Similar Jobs

Project Support Engineer

Salary

Competitive

Location

Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Dublin

Description

Project Support Engineer - Ireland, Dublin - 12 Months Contract One of the top 10 best companies to work in Ireland is looking for a Project Support Engineer for their large-scale new facility in

Reference

37625

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more
Process Equipment Engineer

Salary

Competitive

Location

Sligo

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

West

Description

Process Equipment Engineer - West coast, Ireland - 12 Months Contract Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Process Equipment

Reference

36830

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more
EOHSS Safety Advisor

Salary

Competitive

Location

County Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Dublin

Description

EOHSS Safety Advisor - Dublin, Ireland - 12 Months Contract One of the top 10 best companies to work in Ireland is looking for EOHSS Safety Advisor for their large-scale new facility in Dublin.

Reference

36814

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more

Insights

North Carolina

Living and working in North Carolina
Read more

03/26/2024

Living and Working in Michigan

Living and Working in Michigan
Read more

10/25/2023

Living and Working in Chicago

Living and Working in Chicago

Read more

08/18/2023

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