Reference #: JR114273
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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Summary of Objective:
All activities are focused around technical and operational support to the production, maintenance, and support staffs in the areas of process improvement, equipment modification and optimization, safety and quality improvement, and increasing throughput. This is achieved through individual effort and participation of teams, tracking and analysis metrics, a basic understanding and utilization of good engineering practices, and the use of Lean Six Sigma techniques. Additional responsibilities include supporting the Business Units and plant Operations with serialization tasks and systems.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
For assigned equipment projects, take the primary responsibility for the installation, setup and testing of packaging equipment including but not limited to the following:
Moving and placing equipment
Connecting mechanically and/or electrically
Setting and Testing equipment
Building programs/recipes
Vendor management
Cross functional collaboration
Customer interaction
Equipment Safety
Equipment Reliability
Equipment Performance
Lead the field activities for Process Line Trials (PLT's) and Engineering trials of packaging equipment related topics.
Mechanical equipment
Electrical equipment
Control instrumentation
Troubleshooting
Provide expertise and training to the Mechanical team for packaging equipment related topics as the equipment Subject Matter Expert (SME)
Conducts and/or participates in customer meetings and attends occasional off-site meetings. Interacts with Sales and customers to determine requirements for new products/orders.
Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering.
Prepares Standard Operating Procedures (SOPs), line layouts, production line diagrams as needed.
Assist with Factory & Site Acceptance Testing (FAT/SAT) for all assigned projects.
Develop design criteria and equipment specifications, including safety, regulatory and necessary performance criteria.
Responsible for determining Operational Qualification (OQ) parameters to start validation.
Coordination of outside design, integration, and equipment manufacturing services.
Assist Validation with OQ and Process Qualifications (PQ) of new packaging business.
Write and modify SOPs relating to the production area and assist in training of affected personnel.
Assists with Corrective And Preventative Actions (CAPA) investigations and actions. Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, poor quality and/or unsafe design.
Applies sound engineering principles to improve existing equipment, packaging design and processes by reducing waste, increasing throughput, reducing energy consumption or eliminating human interaction through automation.
Measure and analyze performance metrics of the production area and spearhead initiatives to decrease variability and waste.
Creates and modifies Antares recipes for products run on lines with Antares Tracking System.
Maintains and operates the Antares Warehouse Tracking System (WTS) process.
SUPERVISORY RESPONSIBILITIES:
No supervisory responsibilities.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Office and Production floor environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Associate or technical degree in mechanical science, electrical science or instrumentation control, or minimum of 5-8 years of experience with automated packaging equipment.
Minimum of 3 years of relevant experience in a Lean and/or Six Sigma environment.
Minimum of 5-8 years of relevant experience with packaging equipment.
Lean Six Sigma Background preferred.
Pharmaceutical and/or food packaging background preferred.
LI-DT1
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
