Project Manager
The Project Engineer will work onsite with a major client to safely coordinate and lead projects associated with process improvements, automation, aseptic processing, new processing equipment with some facility/utilities modifications to incorporate same.
The primary responsibility of the role is to ensure that projects meet their agreed goals/targets on time and on budget.
* Safely coordinate and lead cross-functional project teams for the delivery of processing equipment to the site based on planned timelines and scope.
* Processing equipment would include e.g., packaging equipment, assembly equipment, inspection equipment, autoclaves, RABS & isolator filling machines, LAF units, compounding skids, vessels etc.
* Write user requirement specifications.
* Select vendors and complete vendor evaluation matrices.
* Write RCE's, place orders, project management & design review meetings.
* Work to the ASME BPE 2019 standard and relevant ISPE guidelines etc.
* Coordinate processing equipment installation and services hook up, working with equipment vendors and engineering personnel.
* Lead the project team participation in factory acceptance testing programs.
* Coordinate all equipment documentation requirements.
* Commission equipment and provide engineering support during qualification.
Key Requirements:
* 3-5 years' experience in a senior automation/systems engineering or project engineering role in pharma, life sciences or medical devices manufacturing environments
* Project management experience with a proven record of project delivery in pharma, life sciences or medical devices manufacturing environments
* Self-starter with proven technical ability in automation systems engineering
* Good communication and interpersonal skills required to operate in a multi-function project team setup
* Ability to work within a team using your own initiative to articulate and deliver specific functional requirements for all aspects of the project and work with members of various disciplines and functions across the project
* Good team leading skills and ability to work closely with other areas/departments within an organization
About Us:
We specialize in IT solutions to life sciences internationally and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for patients, citizens, employees, end users or customers. We celebrate diversity and are committed to creating an inclusive environment for all employees.