Moulding Validation Engineer
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| Job Type | Contractor |
| Location | Sligo |
| Area | Sligo |
| Sector | Engineering |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 1002812 |
| Job Views | 73 |
- Description
- Team Horizon is seeking a Moulding Validation Engineer (12-month contract) to support our client in Sligo who are a global leader in the biopharmaceutical industry. This role will support a medical device NPI to site.
The department coordinates the specification and functional testing of new equipment in compliance with on-site, corporate, and regulatory requirements. In this role you will liaise with technical subject matter expert (SME) for implementation of new equipment and system definition and with qualification documentation.
You will also maintain and input into the change control program. The role will include providing direction for administrative and/or technical people and/or activities with general supervision.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Coordination / direction and active participation in the validation and qualification of site equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards.
Generation of validation and qualification protocols and final reports to cGMP standards.
Generation of validation investigations and implementation of corrective actions.
Creation/Review/Approval of various qualification documents and test data.
Management of validation, exception event, and change control processes.
Maintenance and tracking of Engineering equipment, if applicable.
Completing all required training before executing a task.
Documenting all activities in line with cGMP requirements.
Updating of Engineering procedures, job instructions and forms to reflect current best practices.
Performing cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
Coordinating activities to maximize the effectiveness of all of the team members.
Maintaining the overall cGMP compliance of the engineering areas.
Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
Required to work as part of cross functional internal and corporate teams.
Provide reports, schedules and timelines for qualification projects in progress to engineering manager.
Assign resources to qualification activities.
Liaise with vendors on system definition and design qualification.
Any other duties as assigned.
EHS Responsibilities:
Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities;
Continually be conscious of your own safety and that of others, always complying with safety notices and barriers;
Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in eAchieve;
Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on eAchieve;
Attend all required EHS training and medical surveillance programs;
Wear PPE as required.
What you need to apply:
Qualification and/or degree in engineering or scientific discipline.
Technical/Business Knowledge -Job Skills
3 years plus validation experience in medical device plastics processing, moulding or assembly operations.
3 years plus of knowledge of cGMP and regulatory requirements relating to the
medical device industry.
2 year plus of experience of validating in a highly automated environment.
Strong communication (written and oral), presentation and troubleshooting skills required.
Effective interpersonal and organizational skills.
Ability to work well both independently and in a team environment.
Capable of prioritizing work and multitasking.
A minimum of 3 years’ experience in a cGMP regulated environment.
Cognitive Skills
This position is crucial in identifying systems and processes requiring qualification assurance support and ensuring that those activities are documented, actioned, and resolved in a timely fashion.
Good communication and motivation ability is required.
Ownership/Accountability
This role is accountable for supporting a positive developmental culture with the organization while ensuring compliance with Quality policies.
Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
The position has a high level of autonomy and individuals are expected to work on their own initiative.
Demonstrates an ethos of Right First Time at all times.
Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company policies, procedures and guidelines.
Shows a high level of tenacity to ensure closure of issues.
Every employee has a personal responsibility to commit to the client’s Vision, to engage and align with the client’s Strategic Imperatives, and to consistently execute in accordance with the client’s Operational Pillars and client’s Ways of Work.
Influence/Leadership
Persuasion and direction skills required to convert thinking of others where gathering acceptance is difficult but important to job performance to maintain standard of engineering qualification projects.
Decision Making/Impact
This position impacts manufacturing, product quality, and technical performance of the product produced at the site location.
Supervision Received
Decision making within confines of agreed responsibility.
Activities broadly defined by agreed goals and company competencies with general management oversight.
Supervision Provided
Close contact with Personnel within the plant at all levels.
Close contact with internal and external auditors, e.g. FDA, IMB
Interaction with other site and TPM personnel in cross-functional activities.
