Gaithersburg, MD 20877
This is a direct hire position
PinPoint Solutions is hiring a Process Engineer
Individual will provide technical engineering expertise within multiple areas of responsibility including engineering, validation and equipment/system maintenance. Develops and recommends new technologies to achieve cost effective and improved equipment/systems robustness. Develops plans and strategy for new product introductions. Establishes operating equipment specifications and improves manufacturing techniques/processes. Supervises direct reports.
- Provide technical engineering oversight from development, to the implementation and routine operation on process equipment/systems.
- Develop documentation to support new equipment implementation (User requirement specifications, Detail design specification, Operating and Maintenance procedures, FAT, SAT, and commissioning documents).
- Perform conceptual analysis of new project proposals; feasibility analysis, scope of work, basis of design, project schedule, budgetary estimate, facility utilization, risk analysis and implementation plan.
- Implement engineering standards and best practices in the design of projects, specification of instruments and equipment, oversee/ coordinate the fabrication, installation and implementation of solutions to process problems.
- Troubleshoot and aid in the repair of process equipment/systems as required to maintain GMP standards for optimal performance. Responsible for ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability.
- Perform deviations/investigations/CAPAs/Change Control write-up. Provide engineering studies, technical engineering support, training and leadership to manufacturing, QA, validation, Quality Control, Validation, Facilities, and Metrology for continuous process improvement, troubleshooting, change control and deviation resolution.
- In areas of health, safety and environmental policy: Provide guidance, leadership and directives to support and comply with all policies. Contribute toward meeting departmental goals and demonstrate progress in preventing or reducing injuries.
- Minimum of bachelor’s degree in engineering (chemical, industrial, mechanical, or related discipline) with 6-8 years of engineering experience in the field of pharmaceutical/biotechnology (or equivalent).
- Strive for Results, Make Decisions, Lead Teams, Develop People, Think Strategically.
- Supervises and manages direct reports in a manner that encourages collaboration and personnel development. Exemplifies and fosters the company core values. Enforces disciplinary actions as needed.
- A self-motivating and goal-oriented individual with proven technical engineering skills. Must have strong oral and written skills with emphasis on technical writing for deviations/investigations/CAPAs.
HKA Enterprises is a global workforce solutions firm. If you're seeking a new career opportunity or project experience, our recruiters will work to understand your qualifications, experience, and personal goals. At HKA, we recognize the importance of matching employee goals with those of the employer. We strive to seek credibility, satisfaction, and endorsement from all of our applicants. We invite you to take time and search for your next career experience with us! HKA is an EEO Employer who participates in the US Citizenship and Immigration Services E-Verify Program.