Pharmavise Corporation logo
Pharmavise Corporation

Excellence through Quality: Pharmavise, your strategic Life Sciences, Healthcare, and Government solutions partner.

Pharmaceutical Manufacturing Specialist – Engineering Background

Software EngineerSoftware EngineerContractRemoteSeniorTeam 11-50Since 2013H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

83 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Pharmaceutical Manufacturing Specialist – Engineering Background

Pharmavise Corporation

• 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.

Job Requirements

  • 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

  • Competitive compensation packages are available

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