Manager, Engineering (Process)

Job Summary

POSITION SUMMARY

Leads the Site Process Engineering team. Responsible for managing engineering functions including process engineering, project management, and computer aided drawing and design. Responsible for the design, procurement, installation, and improvement of site manufacturing and utility equipment as well as facility upgrades and expansions in a cGMP environment. Responsible for the design, fabrication / construction, and implementation of upgrades to existing and / or new facilities, utilities, and equipment.

Directly manages Project Engineers, CAD personnel, Mechanics / Electricians contractors as needed, and interns to meet all regulatory and Company specific policy requirements and to improve plant quality, operational efficiency / effectiveness, capacity, capability, and modernization objectives.

Salary Range : $110,000 - $130,000

Position is eligible to participate in an annual bonus plan with a target of 10% of the base salary.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Manage day to day engineering support functions such as process development, project engineering support and manufacturing support.
• Manage process improvements including area such as the design and upgrade of manufacturing lines and utility systems.
• Manage the startup of new processes and technologies such as clean in place (CIP) / sterilize in place (SIP), aseptic filling, sterilization, serialization and inspection systems.
• Manage engineering studies and cycle developments for new processes and work with Validation team members to qualify processes.
• Manage departmental and capital budgets.
• Assist maintenance and operations in problem solving and process improvements.
• Maintain cGMP, OSHA, and DEC compliance through implementation and adherence to SOP's and governmental regulations.
• Initiate, author, review, and approve change control, specifications, risk assessments, work orders, standard operating procedures (SOPs), capital project approvals (CPAs), purchase requisitions / orders, factory / site acceptance tests (FAT / SAT), corrective actions, and associated interim / final reports and other paperwork in compliance with Company policy.
• Review final documentation packages for all major process systems at the plant including, but not limited to filling operations, packaging operations, steam sterilizers and process washers.
• Participate in and resolve audit and regulatory deficiencies.
• Hire, develop, organize and lead staff.
• Establish and implement appropriate engineering staff training requirements.
• Serve as reviewer and approver for deviation investigations
• Collaborates with the Environmental Management System Representative for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
• Collaborates with the Energy Management System Representative for ensuring that Energy Management Requirements are met under ISO 50001 standards.
• Collaborates with the Occupational Health and Safety Management Representative for ensuring compliance to Occupational Health and Safety is met under ISO 45001.

REQUIREMENTS

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution , andwellness program.

Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.