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Contracting Recruitment Consultant | Assoc CIPD
Process Equipment Engineer - Biologics!
12-Month Contract
This role offers an exciting opportunity for an experienced engineering professional to contribute to the successful delivery of pharmaceutical manufacturing and validation projects. The position involves hands-on support across process and equipment design, commissioning, and qualification, while also acting as a technical subject matter expert for vial filling and isolator systems. With a strong focus on quality, compliance, and cross-functional collaboration, the role supports both ongoing operations and future product introductions in a dynamic, regulated environment.
Responsibilities
* Work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements.
* Develop and modify procedures as needed to support the manufacturing operation.
* Participate in process, equipment, and facilities validations efforts and projects implementations.
* Serve as process and equipment engineering Subject Matter Expert for vial filling and isolator equipment from design phase to equipment handover.
* Review and approve process flow diagrams (PFDs), specifications, layouts, and P&IDs.
* Interface with vendors to ensure alignment in equipment/facility designs and facilitate efficient information transfer between vendor and site.
* Review vendor design documentation to ensure compliance with process and technical specifications.
* Lead FAT and SAT activities, ensuring equipment is designed, fabricated, and tested to meet technical requirements of the project.
* Support equipment installation integration and coordinate vendor supervision as required.
* Support the development of the project commissioning and validation plan.
* Develop commissioning plans for all process-related equipment ensuring compliance with Good Engineering Practice (GEP).
* Review all process-related validation protocols for completeness and accuracy.
* Execute protocols in a timely manner to meet project schedule requirements.
* Participate in design and process project conversations to ensure reliability by design is incorporated prior to equipment arrival.
* Lead manufacturing and validation activities during the project life cycle.
* Support technical transfers for future product introductions to the site.
* Assess and own the relationship between process requirements and unit operation equipment.
* Understand the impact of equipment control systems on processing performance.
* Investigate process exceptions or equipment malfunction incidents affecting the process.
* Liaise with operations, quality, and S&T to ensure equipment and process performance is maximized.
* Collaborate with internal/external engineering personnel and contract maintenance providers for troubleshooting, installation, and commissioning.
* Implement equipment/process upgrades in a continuous improvement environment.
* Support the Production Team to ensure that manufacturing equipment is maintained to meet output and yield requirements.
* Adhere to all relevant policies relating to Quality & Safety.
* Ensure successful external inspections, and Division and Corporate audits.
* Supervise external contractors.
Requirements
* A relevant third-level qualification in an engineering, science, or technical discipline (Degree level or Masters preferable).
* At least 4 years of total combined experience in Process / Equipment or Manufacturing Engineering within a Pharmaceutical and Health Care Organization.
* At least three 2 years of experience in a manufacturing environment of a biotechnology, pharmaceutical, or health care plant.
* Preferable experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, and sterilization operations.
* Desirable experience in new product introductions (drug product) to pharmaceutical facilities.
Cognitive Skills
* Proven problem-solving skills under pressure.
* Requires detailed evaluation of multiple viable solutions for each problem.
* Requires innovative thinking and implementation of new and untested solutions.
* High attention to detail and mental concentration to ensure accuracy and compliance at all times.
* Results-driven with a strong focus on meeting targets and performance metrics.
* Total commitment to quality and high standards of work.
* Demonstrates the highest levels of integrity and a strong work ethic.
* Strong verbal and written communication skills.
* Strong interpersonal skills.
* Understands and supports the principles of Perfect Performance.
Ownership / Accountability
* Commit to the organization's Vision, engage with Strategic Imperatives, and consistently execute in accordance with Operational Pillars and Ways of Work.
* Accountable for supporting a positive developmental culture while ensuring compliance with Quality policies.
* Requires good knowledge of Company Policies and Procedures; works towards general results to meet organizational needs.
* Operates with a high level of autonomy and initiative.
* Demonstrates a Right First Time ethos at all times.
* Adheres to procedures and ensures compliance with cGMP, ISO/FDA regulations, and company policies.
* Displays high tenacity to ensure timely issue resolution.
Influence / Leadership
* May support cross-functional teams and cost improvement projects.
* Provides technical leadership and collaborates with key stakeholders.
* Contributes to successful delivery of site CJRs and goals.
* Leads delivery of new training initiatives.
* Exercises considerable latitude in determining technical objectives of assignments.
* Expected to handle all training, learning & development queries, referring to Team Manager only for major issues.
* Presents technical data to stakeholders to enable prompt decision-making.
Apply today!
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Contract
Job function
* Job function
Engineering and Quality Assurance
* Industries
Pharmaceutical Manufacturing
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