The Process Engineer will support a state-of-the-art pharmaceutical repackaging operation. This role will focus on insuring process quality and cost effectiveness, while improving safety, compliance, and customer service. This individual will; Support the management team in the development, planning, implementation and control of operations, production processes, logistics, and maintenance for new or existing products and technologies; Will work closely with the team to ensure strict compliance with Current Good Manufacturing Practice guidelines and SOPs at all times; Prepare documentation, machine and system validation protocols, reports, and standard operating procedures as required; Provide guidance on the effective use of materials, equipment, and labor in producing quality products; Monitor labor and other expenditures; Assist in developing budgets; Recommend production policies, procedures, and programs. Individual may also manage a variety of projects including, but not limited to analysis, design, process improvement, capacity, new equipment, material handling systems and technology changes. The position reports to Senior Director and will closely coordinate work with Quality and Operations Departments.
* Pursue process excellence in a lean and continuous improvement-production environment.
* Provide leadership, guidance and support for process improvement projects.
* Develop and present proposals related to improving product quality and process efficiency.
* Maintain competency on current GMPs and industry practices through research, training, courses, etc.
* Support the development, implementation, and maintenance of cGMPs, standard operating procedures, and operating guidelines within the facility. This includes compliance with FDA, DEA, EPA, OSHA, and other regulations.
* Assist in investigating customer complaints and non-conformances related to operational functions thoroughly and within designated time lines.
* Assess methods and procedures to ascertain the most efficient/effective way to perform tasks. (Reducing steps, travel, non-value added time, and waste, deploying best practices, work simplification, staff planning, balancing, and identification/removal of barriers to productivity).
* Provide management team with necessary support and guidance for improving utilization of resources (direct and indirect labor, equipment, space, supplies, etc.)
* Assist in the recommendation and justification of capital investments in equipment and technology for the operation supported by financial analysis and consistent with strategic objectives.
* Perform validation testing of new and existing equipment and systems.
* Develop equipment and system validation plans and documents.
* Assist team in preparation of short term and long-term budgetary planning based on CVS Health’s goals and growth objectives.
* Other duties as assigned; Job duties may vary by location
* Display behavior which exemplifies CVS Health’s Code of Conduct and Values.
* Follow all applicable government regulations including HIPAA, FDA, OSHA, DEA and EPA.
* Regular attendance is an essential function of the job.
* Minimum (Required) Qualifications: (must be met in order to perform the job at the required level)*
* EDUCATION: B.S. Degree in Engineering; Process, Manufacturing, Packaging or similar combination of education and experience.
* EXPERIENCE:
o 5 years’ experience in FDA or similarly regulated industry.
o Have a history of successful project management experience.
* SOFTWARE PROFICIENCY:
o Microsoft Office, including MS Access
o AutoCAD
o SQL
* MUST:
o Effectively manage multiple tasks/assignments.
o Be able to build positive working relationships with all colleagues, customers and business partners.
o Demonstrate excellent analytical, problem solving, and decision-making skills.
o Demonstrate excellent interpersonal, written and oral communication skills.
*Preferred Qualifications: (if above and beyond the minimum required)*
* Knowledge of Current Good Management Practices (cGMP) for pharmaceuticals.
* Pharmaceutical packaging experience including thermoforming and related tooling experience.
* Familiarity with equipment cleaning methods, cleaning validation.
* Strong knowledge of industry and management methodologies such as ISO 9000, Total Quality Management, or Lean Six Sigma.
* User Specification Requirements (USR), Factory and Sight Acceptance Testing (FAT/SAT) process and documentation
* Statistical sampling, SPC
* Vision systems experience
* Lot change / economic lot sizing techniques
* Equipment calibration
* Time study methods
* Economic evaluation / capital expenditure justification (Engineering Economics)
* Logistics
* Workload balancing, production planning and scheduling methods
*Physical Demands:*
May sit, stand, stoop, bend and walk intermittently during the day. May sit or stand seven (7) to ten (10) hours per day. May be necessary to work extended hours as needed. Finger dexterity to operate office equipment required. May need to lift up to twenty-five (25) pounds on occasion. Visual acuity to see and read fine prints. Specific vision abilities required by this role include close vision, color vision and the ability to adjust focus. Must be able to hear normal voice sounds. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this role.
*Work Environment:*
Work in a climate-controlled, smoke-free internal environment.
*Equal Opportunity Employer:* Omnicare is fully committed to employing a diverse workforce. We recruit and retain talented individuals without regard to gender, race, age, marital status, disability, veteran status, sexual orientation and gender identity or any other status protected by federal, state or local law. Omnicare is an Equal Employment Opportunity and Affirmative Action Employer.
EO/Minorities/Females/Disabled/Veterans
Omnicare, Inc. is a wholly owned subsidiary of CVS Health Corporation. www.cvshealth.com
*What We Do*
Directly, and through our subsidiaries, Omnicare provides a broad array of pharmacy-related services to long term care facilities and to other customers in the health care environment. While senior care has long been an Omnicare specialty, we also serve other targeted populations.
*Commitment at Every Level*
A large part of Omnicare's success derives from a commitment, at every level, to the welfare of each individual we serve. Each day, our employees consider how their work can improve the quality of life of residents and patients. Omnicare is truly a health care company, working to improve the health and quality of life for everyone we touch.