Manufacturing Technology Engineer I

HKA Enterprises; Rocky Mount (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

HKA Enterprises is seeking an experienced Manufacturing/Process Engineer with strong validation and qualification background to support pharmaceutical processes and equipment validation, documentation, and regulatory compliance. Responsibilities include leading studies, change control, data review, and participation in audits, with collaboration across QC, regulatory, and operations.

Strong written/verbal communication and Excel data analysis are essential, with attention to detail and

Qualifications

• Pharmaceutical validation/qualification experience required.
• Experience with FDA regulations and cGMPs.
• Strong documentation and reporting skills.

Responsibilities

• Draft, schedule and execute engineering studies per SOPs and regulatory guidelines.
• Coordinate testing with affected groups and evaluate results.
• Lead change control initiation, protocol prep, periodic reviews, and data review.
• Support audits with data presentation and findings.
• Participate in cross-functional teams for process tech transfers and equipment validation.
• Develop and qualify production recipes for manufacturing processes.
• Review manufacturing and packaging records for compliance with policy and cGMPs.
• Create, review and approve deviations.
• Define corrective actions and communicate closures.
• Coordinate project work to meet deadlines from capital plans and NPI efforts.
• Provide manufacturing engineering support and new process development.
• Organize testing for new process technologies and tech transfers.
• Collaborate with site tech services to define critical process parameters.
• Deliver presentations on timelines and milestones.
• Prepare study designs and technical reports to support process development.

Skills

Attention to detail

Organizational skills

Communication skills

Independent work

Initiative

Pharmaceutical validation/qual

Regulatory knowledge

Education

HS Diploma or Equivalent

Associate’s Degree

Bachelor’s Degree

Tools

Microsoft Office

Excel

Job description

Key Responsibilities

• Draft, schedule and execute engineering studies/validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines.
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Execute engineering activities to include, but not limited to: Change Control initiation, protocol preparation, periodic reviews, routine requalification, scheduling, protocol execution, data review and final report generation.
• Participate and/or present data in Regulatory Agency, Customer, Corporate and Internal audits when necessary.
• Participates on teams assembled to specify, install, validate, troubleshoot and maintain processes, systems and equipment.
• Develop and qualify production recipes for manufacturing processes.
• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conform to company policy and cGMP's.
• Create, review and approve deviations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.
• Coordinates all work on scheduled projects needed to meet the deadlines developed by Plant Capital Plan, New Product Introductions, and New Process Technology Developments.
• Responsible for manufacturing engineering support, the development of new process technologies, and the support of new product introductions/tech transfers.
• Organizes testing associated with the development of new process technologies and the support of new product introductions/tech transfers.
• Works closely with site tech. services to develop and confirm Critical Process Parameters needed for Equipment and processes.
• Develops and delivers presentations to communicate project timelines and milestone completions.
• Design technical/engineering studies, writes technical reports summarizing study results and generates necessary data to support process development for new equipment, process changes, commodity changes and/or investigation/CAPA support.
• Generate/Support site technical assessments (i.e., alarm, risk, engineering).

Role Requirements/ Qualifications

• Applicant must have a HS Diploma (or Equivalent) and 6 years of relevant experience OR an associate's degree with 4 years of experience OR a bachelor's degree with 0+ years of experience.
• Excellent attention to detail.
• Excellent organizational skills, and ability to handle changing deadlines.
• Strong communication with written and verbal skills.
• Working knowledge of Microsoft Office, especially Excel for evaluation of data.
• Nice-to-have/ Preferred Technical writing experience.
• Experience with pharmaceutical industry validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices.
• Working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices.
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.