Packaging Engineer – New Jersey
The primary responsibilities of this role, Research Scientist, Packaging Development, are to provide strategic direction and support to multiple projects that directly impact the company profitability. Successfully executes multiple projects in a cGMP environment and understands regulatory and quality assurance requirements. These teams develop a general understanding of the plant processes and products and can provide technical support to all manufacturing areas.
- Provides strategic direction and support to multiple projects that directly impact the company profitability. Successfully executes multiple projects in a cGMP environment and understands regulatory and quality assurance requirements. These teams develop a general understanding of the plant processes and products and can provide technical support to all manufacturing areas.
- Manages the preparation of Capital projects from inception through execution into a production state. Executes project documentation including but not limited to conceptual ideas, costing options, project plans, Factory Acceptance and Site Acceptance testing, installation, commissioning protocols, qualification strategy/protocols, and project closeout. Oversees creation of documentation packages, which include data review and summary of each assessment to ensure compliance with cGMPs. Provides regular report-outs to site senior management on the needs of the operation and the results of the project document packages.
- Leads the Process Engineering Team to deliver exceptional customer service in the key areas of safety, quality, costs, and team development.
- Coordinates project management processes that provide the tools to effectively initiate scope and execute projects that exceed our customer requirements in the areas of on time, on budget and meet specifications.
- Partners with Manufacturing, Validation, Utility Services, Maintenance, Metrology, Quality and support labs to assure effective communication on problems, issues, and schedules related to project engineering and manufacturing support.
- Support capacity and efficiency improvement projects by providing engineering resources to meet stage gate deliverables and project objectives.
- Provides strategic direction and support in developing innovative design solutions to complex problems. Anticipate potential problems and design preventative solutions.
- Contributes in developing departmental policies, programs, SOPs, and engineering standards to meet current industry, corporate Quality, and external Regulatory requirements.
- Responsible for growing the culture of personal engagement, ownership, customer service and accountability towards achieving and exceeding project expectations. Communicate concerns, needs and recommendations to upper management.
- Ensure compliance of projects with all relevant local, state and federal safety and environmental regulations, guidelines, and policies. Also ensure compliance with FDA/cGMP regulations guidelines and policies.
- Demonstrate personal commitment and takes action to stay current regarding industry related new and emerging technologies that will continuously improve manufacturing efficiencies, quality and safety.
- Accountable for all project performance/KPI’s to ensure results are delivered as expected with the ability to communicate to results to Senior Management.
- Responsible for the performance and development direct reports through regular feedback, setting goals, establishing personal development plans, measuring performance and creating a readiness pipeline for future senior engineering and leadership roles.
- Participates in department and capital budget preparation. Ensure budget, schedules and performance requirements are met.
- Subject Matter Expert (SME), reviewer, and/or approve of controlled documents within area(s) of expertise.
- Other tasks as required by Department Management.
- 7 years Engineering experience within a pharmaceutical/biotherapeutics manufacturing operation.
- Extensive experience in cGMP and FDA regulated environments. Knowledge of
- and familiarity with other plant operations, such as Manufacturing, QC/QA, etc.
- 5 Years of management and leadership experience
- Demonstrate sense of urgency and sound judgment in a fast-paced environment
- Demonstrate ability to motivate and lead team
- Demonstrate analytical and problem-solving skills using data to draw conclusions and implement solutions
- Demonstrated ability to develop others
- Excellent written and verbal communication skills with the ability to speak to a diverse audience spanning from staff to executive levels.
- Outstanding interpersonal skills and ability to collaborate with and include others in the organization locally and global.
- Proficient in MS Excel, MS Project, Word, PowerPoint and Outlook
With more than 100 different animal health products worldwide for both livestock and companion animals, this Fortune 100 company is one of the most successful suppliers in the field of veterinary medicine. The Animal Health industry is rapidly expanding, and my client is well positioned for steady growth and in the midst of expanding their facility. They routinely rank among Fortune Magazine’s “Most Desired Companies to Work for.”