Job Overview: We are seeking a highly experienced and motivated Manufacturing Science and Technology (MTS) Engineer III to join our dynamic pharmaceutical manufacturing team. The MTS Engineer III will play a crucial role in ensuring the success of our manufacturing operations by utilizing their expertise in aseptic techniques, tech transfer, fill/finish processes, change controls, and process optimization. This is an on-site position that requires a minimum of 5 years of industry experience in pharmaceutical manufacturing, with a strong background in GMP environments.
Key Qualifications:
- Bachelor's degree in Engineering, Pharmacy, Life Sciences, or a related field.
- Over 5 years of hands-on experience within the pharmaceutical manufacturing industry.
- In-depth knowledge of aseptic techniques and practices in a GMP environment.
- Proven expertise in tech transfer and fill/finish processes.
- Strong background in change controls and process optimization.
Job Duties and Responsibilities:
Troubleshoot Manufacturing Operations: Collaborate with manufacturing staff to identify and resolve technical issues and challenges related to the production processes. Provide technical expertise to ensure smooth and efficient operations.
Technical Documentation: Prepare and compose detailed technical documents, including batch records, Standard Operating Procedures (SOPs), protocols, engineering runs, validation reports, and other relevant documentation. Ensure that all documents comply with regulatory guidelines and industry standards.
Equipment Design and Selection: Participate in the design, evaluation, and selection of small scale equipment used in manufacturing processes for client products. Ensure that equipment meets quality standards, safety requirements, and is cost-effective.
Tech Transfer and Fill/Finish Support: Lead and support technology transfer activities from development to manufacturing, ensuring seamless integration of new products and processes into the production environment. Oversee fill/finish processes and provide technical support to ensure product integrity.
Process Optimization: Continuously assess manufacturing processes and systems to identify areas for improvement. Implement process optimization strategies to enhance efficiency, yield, and product quality.
Cross-Functional Team Support: Collaborate with various onsite teams, including manufacturing, operations, validation, and quality assurance, to support projects and resolve technical issues. Foster effective communication and teamwork to achieve project goals.
Compliance and Regulations: Ensure that all activities and processes adhere to GMP guidelines, safety regulations, and industry standards. Participate in audits and inspections as needed, addressing any findings promptly.
Continuous Learning: Stay updated with advancements in pharmaceutical manufacturing technologies, aseptic techniques, and industry best practices. Share knowledge and provide training to other team members as required.
Risk Management: Identify and mitigate potential risks associated with manufacturing processes. Develop and implement contingency plans to address unforeseen challenges.
Skills and Competencies:
- Proficient in aseptic techniques and GMP regulations.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Detail-oriented with the ability to maintain accurate and organized records.
- Ability to work effectively in cross-functional teams.
- Project management skills with the ability to prioritize tasks and meet deadlines.
- Familiarity with regulatory requirements and industry guidelines.
The Manufacturing Science and Technology (MTS) Engineer III role offers an exciting opportunity to contribute to the success of our pharmaceutical manufacturing operations. If you are a skilled and experienced professional with a passion for process optimization and delivering high-quality products, we invite you to apply and join our innovative team.
