Overview
The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands.
We are looking for a Process Expert / Process Engineer to join our dynamic and innovative OTS team, working on a client site. The Process Expert will have comprehensive knowledge of plant operations and cleaning technologies, to support production onsite, ensuring processes are optimized, compliant and efficient throughout the production lifecycle. They will also support project implementation.
Responsibilities
1. Lead initiatives to optimize and enhance the API and excipient production processes. This includes identifying areas for improvement, recommending changes, and implementing solutions that increase efficiency, yield, and cost-effectiveness.
2. Provide hands-on support to resolve technical issues during production. Use a data-driven approach to diagnose and address root causes of process deviations and production challenges.
3. Ensure all processes meet regulatory requirements, GMP (Good Manufacturing Practices), and safety standards. Support the preparation and review of documents for regulatory audits and inspections.
4. Utilize advanced process monitoring tools to track production performance, identifying any discrepancies or areas of concern. Implement corrective actions as necessary to maintain smooth operations.
5. Work closely with other departments including Engineering, Quality Assurance, and Production teams to ensure seamless communication and process alignment.
6. Provide training and mentoring to production teams, ensuring they are equipped with the necessary knowledge and skills to follow best practices and adhere to process specifications.
7. Maintain detailed process records and reports for production batches, troubleshooting activities, and continuous improvement projects. Ensure all documentation is accurate and up to date for audit purposes.
Qualifications
1. Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, Bioprocessing, or a related field.
2. Minimum of 5 years of experience in pharmaceutical production, specifically in API or excipient manufacturing.
3. Strong understanding of process engineering, process optimization, and troubleshooting in a regulated pharmaceutical environment.
4. Knowledge of GMP, safety regulations, and industry standards.
5. Familiarity with production systems, automation tools, and data analysis software.
6. Excellent problem-solving skills and ability to work independently and collaboratively.
7. Strong communication skills, with the ability to work effectively across teams and departments.
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