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Pharmaceutical Manufacturing Specialist – Engineering Background
Pharmavise Corporation. Support pharmaceutical manufacturing operations by applying engineering principles and expertise to optimize processes, equipment, and facilities.
About the role
Key responsibilities & impact- Support pharmaceutical manufacturing operations by applying engineering principles and expertise to optimize processes, equipment, and facilities.
- Collaborate with cross-functional teams, including manufacturing, process development, quality assurance, and regulatory affairs, to ensure efficient and compliant manufacturing operations.
- Lead or participate in process improvement initiatives, including the identification, evaluation, and implementation of new technologies, equipment, and manufacturing practices.
- Conduct risk assessments and develop risk mitigation strategies for manufacturing processes, equipment, and facilities to ensure product quality and compliance with regulatory requirements.
- Provide technical support for troubleshooting manufacturing issues, deviations, and investigations, and implement corrective and preventive actions (CAPAs) as needed.
- Support the design, installation, qualification, and validation of manufacturing equipment and facilities, including process equipment, utilities, and cleanrooms.
- Develop and maintain manufacturing documentation, including standard operating procedures (SOPs), batch records, and equipment qualification/validation documentation.
- Stay abreast of industry trends, advancements, and regulatory requirements in pharmaceutical manufacturing and engineering, and apply best practices to drive continuous improvement.
Requirements
What you’ll need- Bachelor's degree in engineering (chemical, mechanical, electrical, or related discipline) required; advanced degree preferred.
- Minimum of 5 years of experience in pharmaceutical manufacturing or related industry, with a focus on engineering support for manufacturing operations.
- Strong understanding of pharmaceutical manufacturing processes, equipment, and facilities, including solid dosage forms, liquids, and sterile products.
- Experience with process improvement methodologies, such as Lean Six Sigma, and demonstrated ability to drive efficiency and quality improvements.
- Knowledge of regulatory requirements and guidelines governing pharmaceutical manufacturing (e.g., cGMP, FDA, EMA) and experience with regulatory inspections and audits.
- Proficiency in engineering software and tools for process simulation, equipment design, and data analysis.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
- Ability to work independently and manage multiple projects simultaneously, with a strong focus on results and attention to detail.
Benefits
Comp & perks- Competitive compensation packages are available
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmaceutical manufacturingprocess improvementrisk assessmenttroubleshootingcorrective and preventive actionsequipment qualificationvalidationprocess simulationdata analysisLean Six Sigma
Soft Skills
communicationinterpersonal skillscollaborationindependenceproject managementattention to detailresults-oriented
Certifications
Bachelor's degree in engineeringadvanced degree in engineering