Process Engineer

Found in: Talent IE C2 - 2 weeks ago

Cork, Ireland emagine Consulting Full time

Want to make an impact? We offer that

 Due to continued growth, we are currently hiring a Process Engineer to join our team. emagine is a dynamic, fast-growing international consulting and technology company, founded on real-world experience, focused on custom-fit solutions. We have the proven people and expertise to complete complex projects, while delivering lasting knowledge-transfer benefits to empower our partners for the next challenge .

Are you intrigued? Do you want to learn more?

A snapshot of your key responsibilities as a Process Engineer would be:

Enable the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements.

Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.

Coordinate the implementation of new procedures.

Enforce fulfillment of the GMP and HSE policy, by supporting inspections and liaising with other Areas.

Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget)

Prepare manufacturing plans for production lines, managing resources allocation and assigning the members responsible (when applicable) for specific tasks.

Responsible for the accurately and timely preparation, review and approval of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, cost proposals, validation plans and validation reports and other GMP related documentation for all processes run in operations.

Supervise, execute and ensure, with autonomy, all risk assessments for assigned activities and projects

Report, investigate and document any abnormal observations, potential risks, discrepancies, deviations and non-conformances in accordance with internal procedures.

Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate.

Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals.

Act autonomously as the lead process engineer in multiple projects of high-complexity and/or with significant impact on business and liaises directly with customer project team, promoting active and transparent communication, including in complex situations.

Provide training on manufacturing processes, production systems and procedures to operational team members.

Oversee the activities of less experienced Engineers, ensuring that they have the right resources and the right knowledge to do their job and to reach the defined objectives.

Support internal stakeholders on, including but not limited to, generation of 3P’s and answering queries on cost and cycle time associated with assigned processes (where applicable)

Support commercial assessment requests for business evaluation / technical introduction within the area.

Assist with audits and investigations as SME for Operations.

Approve changes to facilities and/or equipment trains, when delegated by n.

Promote the transfer of strong engineering expertise amongst other members of team, sharing knowledge of state-of-the-art technologies and methodologies within the area.

Initiate and prepare tech-transfers and process improvement projects for established and new processes utilizing best available technology, practices and tools.

Contributes to the increase of productivity by reviewing, proposing, planning, coordinating and leading the implementation of new technologies, methods and

Implement the actions derived from approved Area budgets, contributing to costs control and to the achievement of P&L targets.

Requirements:

Degree in a field of Science or Engineering (with a preference in Chemical Engineering)

5+years experience working within the pharmaceutical industry in Pharmaceutical Fine Chemistry and/or Particle Engineering and/or Drug Product (areas of development, scale-up and production) (mandatory)

Training and experience in GMP and HSE practices (mandatory)

Experience in technical manufacturing support

Experience of multiple projects and product from early stage development to commercial scale

Strong interpersonal skills to enable effective interactions with stakeholders (written and verbal)

Expertise or significant experience in other departments or areas in a Pharmaceutical organization such as Quality Assurance, Analytical Development, Quality Control, Project Management, Process R&D, from completed assignments or past job experience (preferable)

Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

So, are you ready to join our team?

 It’s important to remember, emagine is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for our customers.

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