National Service Ops Mgr
City	Parsippany
State	NJ
Description	Summary: Directs Field Service Group activities directly or through others by coordinating and managing field service group and hotline groups to ensure customer satisfaction by performing the following duties:Job Duties: • Staffs, trains, monitors and mentors team. • Manages the field service group and hotline groups to provide support services to internal and external customers. • Manages day-to-day activities of the field service engineers to include: prioritizing, scheduling, special projects, etc. • Drives FSG Escalation Process, including data tracking, compliance, resource allocation, and direct customer interface. • Reviews performance reports and documentation from customers and field representatives, to verify compliance. • Responds to and resolves customer inquiries regardless of the complexity. • Completes, maintains and processes pertinent paperwork and records. • Ensures staff compliance with all SOPs, company programs and initiatives. • Ensures staff is trained to help customers use products properly. • Ensures technical and process competencies with the field service engineers and hotline employees. • Advises upper management on product issues arising from product problems identified through customers. • Plans levels of support according to product release schedules. • Forecast and manages budget to ensure adherence to guidelines. • Actively collaborates with all departments with a goal of continuous improvement. • Responsible for the ERP applications related to service activities and processes. • Operates the department within established FDA regulations. • Works with Regulatory/Quality Affairs to establish SOP’s for the department, continuous quality improvement. • Assures integrity and consistency of the instrument install based by following proper implementation procedures of retrofit per manufacturer guidelines. • Handles customer issues when arise and regularly visits customer sites to improve customer satisfaction. • Manages service contracts process with special attention to PM and TSB execution. • Implements regular customer service surveys and takes necessary actions. • Participate in internal and external audits. • Responsible for the creation of all Operational reports including PM, TSB, FSE Metrics, TSS Metrics, and Hotline Metrics. Skills: • Should have knowledge of Database and Internet software; Spreadsheet software and Word Processing software. Company usable software. • Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations. • Ability to write reports, business correspondence, and policy manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Education & Requirements: • B.S. degree in related field required, with 5 to 7 or more years related experience. • 3 years management experience. • Ability to travel domestically and internationally, if needed. Up to 75% overnight travel. • Current Driver’s License, Valid Passport Forward Resumes to: larson@jobsbl.com

 

Tooling and Equipment Coordinator

Essential Job Function:

The Tooling and Equipment Coordinator must be able to carry out all Tool Room and support equipment duties as required. Must have the skills to perform the setup, troubleshooting and maintenance of process support equipment. This includes efficiency improvements and advance preparation techniques. Must undergo both internal and external training to be at the forefront of skills and techniques to continually increase the knowledge base associated with advance preparation techniques and new Operating Procedures.

The Tooling and Equipment Coordinator must be able to communicate in written and verbal English. Must have the ability to perform mathematics (addition, subtraction and multiplication). Must be capable of lifting material/equipment up to 60 lbs or manipulating material up to 200 lbs. Will be required to read, comprehend and comply with cGMP regulations in conjunction with Standard Operating Procedures.

The Tooling and Equipment Coordinator must be trained by a certified tooling manufacturing company or equivalent.

 General Information:

Responsibilities to include, but not limited to:

 General

1. Excellent organizational skills coupled with strong mechanical ability and willingness to be a “hands-on” employee.
2. Perform, assist, oversee and coach tasks performed by Entry-Level Operators as requested by the Manager of Operations.
3. Perform all duties supporting and surrounding manufacturing independently; with minimal or no supervision required.
4. Understand processing instructions and process flows of products to be able to anticipate upcoming equipment needs that may be required.
5. Full knowledge of various equipment including tablet presses, encapsulation equipment, fluid beds and associated support equipment.
6. Immediately communicate any deviations or problem issues to the Management.
7. Cooperate with fellow employees and Supervisors especially with respect to working together safely and in accordance with cGMP to get the required work done.
8. Responsible for troubleshooting and making minor repairs to keep support equipment operating within specs.  Contact Supervisor and Facilities for major support equipment repairs.
9. Responsible for maintaining Production Logbooks and overseeing entries made by Manufacturing, QA and Maintenance personnel.
10. A minimum high school education or GED with college preferred. The position is classified as “safety sensitive” and is subject to random drug testing and background check. 

Equipment

Responsibilities to include, but not limited to:

1. Will organize, maintain, and be responsible for support equipment including but not limited to spray nozzles, wands, mixers, fluid bed bottom screens and filters, Wurster plates, pumps, tubing, pump heads, pick up tubes, hardness testers, thickness gauges, Sweco screens, Fitzmill screens, Glatt sieve parts, VG parts and filters, pan coater nozzles and parts, CPS nozzles and parts.
2. Work with vendors and Management to prepare RSPL (Recommended Spare Parts Lists) for equipment.
3. Train employees on the use and care of support equipment as deemed necessary by Management.
4. Order new support equipment based on approval of the Manager of Operations.
5. Coordinate equipment movement with Operations Supervisors and the Warehouse.
6. Assist Management in performing a Gap Analysis of current equipment procedures and, if deemed necessary, co-author any procedure revisions.
7. Assist Validation Group on an as needed basis with equipment IOQs under the direction of the Manager of Operations.
8. Review the Weekly Production Schedule and determine the equipment needs of each lab and assure required equipment is staged prior to processing and in good working order.
9. Other tasks as assigned Supervisor and Management.

 

Tool Room 

Responsibilities to include, but not limited to:

1.  Perform all procedural tasks as outlined in the following SOP’s:

• SOP No. 5007.04 – Tooling Preparation.
• SOP No. 5010.03 – Polishing of Press Tooling.
• SOP No. 5021.03 –Tableting Tooling Receiving and Storage, Use Documentation and Inspection.
• SOP No.  5071.00 – Cleaning Procedure for the Modu-C HH-0006.016 Capsule Filler.

2. Clean and maintain all tablet machine punches and encapsulator machine parts.
3. Polish punches, when necessary.
4. Create and maintain a Tooling Log Book for each set of punches.
5. Assign a Tooling Set Number and identify on Tooling Storage Boxes.
6. Inspect and measure Tooling.  Document all inspection and measurements on the appropriate forms.
7. Document Tooling usage.
8. Report any and all Tooling damage to the Manufacturing Manager.  No Tooling is to be discarded without documentation and proper Management approval.
9. Assure the Tool Room is locked when unattended and do not issue your access code to anyone.
10. Perform Tooling cleaning tasks to support Manufacturing, other departments and facility readiness.
11. Perform proper documentation in compliance with cGMP regulation and company policy in a clear and legible manner.
12. Maintain standards of being on time to work, taking breaks and lunch at assigned times and ensuring time at work is accounted for properly.
13. Assist Operations and Formulation with new Tooling Orders and maintain all Tooling drawings.
14. Provide training to CM Operators on proper use and handling of compression and encapsulation Tooling.
15. Meet with equipment vendors on an as needed basis.
16. Responsible for following all safety rules and procedures.
17. Other tasks as assigned by Management.

Equipment

Responsibilities to include, but not limited to:

1. Will organize, maintain, and be responsible for support equipment including but not limited to spray nozzles, wands, mixers, fluid bed bottom screens and filters, Wurster plates, pumps, tubing, pump heads, pick up tubes, hardness testers, thickness gauges, Sweco screens, Fitzmill screens, Glatt sieve parts, VG parts and filters, pan coater nozzles and parts, CPS nozzles and parts.
2. Work with vendors and Management to prepare RSPL (Recommended Spare Parts Lists) for equipment.
3. Train employees on the use and care of support equipment as deemed necessary by Management.
4. Order new support equipment based on approval of the Manager of Operations.
5. Coordinate equipment movement with Operations Supervisors and the Warehouse.
6. Assist Management in performing a Gap Analysis of current equipment procedures and, if deemed necessary, co-author any procedure revisions.
7. Assist Validation Group on an as needed basis with equipment IOQs under the direction of the Manager of Operations.
8. Review the Weekly Production Schedule and determine the equipment needs of each lab and assure required equipment is staged prior to processing and in good working order.
9. Other tasks as assigned Supervisor and Management.

Resumes forward to: larson@jobsbl.com

 

 

Lead Process Technician

Essential Job Function: This position carries the responsibility for the direct client interface during the development; scale-up, transfer, and /or commercialization of products. This includes batch record creation, review, generation of DOE and sampling protocols, validation documents, authorship of final reports and technical project guidance to the client.

Expertise in fluid bed processing is highly sought as well as high shear granulation, drying, milling/sizing, compression, encapsulation, coating and packaging operations are fundamental requirements for the position.

This position is also accountable for the training and mentorship for junior personnel within the R&D, Technical Process Operations and Manufacturing Operations.

This position is classified as a “safety sensitive” position especially in light of our formulation and development work with controlled substances and is therefore subject to random drug testing.

General Information: Bachelor’s degree or equivalent Industry Standard Certification and +10 years related pharmaceutical experience. Position requires a demonstrated skill for scientific report writing, excellent verbal communication skills, and a customer oriented behaviors.

Responsibilities include but not limited to:

• Direct client interface during the development, scale-up, transfer, and /or commercialization of products. This position has the obligation to meet or exceed the Client’s expectations set forth in the Statement of Work. This includes both the delivery of “hard” documents (DOE protocols, interim/final Product reports, validation documents, etc.) and driving major activities to meet project milestones and goals as stipulated in the Statement of Work.

• Identification of critical scale-up and process validation parameters for each project, in close association with Technical Process Operations and Commercial manufacturing.

• Liaise with Business Development, Planning, QA, Contract Manufacturing, and Development on behalf of external client projects.

 

• Provide guidance and mentoring to junior scientists and Technicians. Specific activities would include, 1) review of data summaries, 2) mechanical set-up, maintenance, and running of equipment, 3) cGMP and OSHA operating standards, 4) review of lab notebooks and process reports for completeness and accuracy.

• Technical and process training to CM personnel as part of product transfers or new product introductions.

• Ability to carry out complex work assignments in a high quality work environment.

• Liaise with Project Manager for guidance and coordination of Development and Tech. Process supported activities.

• Serve as a process technology expert for new unit operations installed in laboratory as assigned. Activities include gaining an intimate scientific, mechanical, systems knowledge of these new processing systems.

• Support Product Development/Formulations, Technical Services, and Business Development with client and affiliated process transfers.

• Assimilate R&D and Process Development product data to devise commercial scale processes which are valid table and cost effective.

Resumes forwarded to larson@jobsbl.com

Summary: Sells company products with emphasis on Instrumentation by performing the following duties;

Job Duties:
• Generates and maintains lists of prospective customers for instrument sales leads.
• Travels throughout assigned territory to call on regular and prospective customers to solicit orders, or for instrument sales.
• Displays or demonstrates product, using all available and supported  tools, and emphasizes salable features.
• Quotes prices and credit terms and prepares sales contracts for orders obtained.
• Enters new customer data and other sales data for current customers in the Company selected CRM.
• Develops and maintains relationships and demonstrates an ability to utilize available resources.
• Demonstrates Instrumentation including setup and break down.
• Meet company assigned individual sales goals.
• Generates and maintains an accurate 30-60-90 day sales funnel of prospective customers for instrument sales leads.
• Prepares detailed proposals and financial for instrument and reagent sales, completes IPO’s in a correct and timely manner and to facilitate instrument delivery and customer training
• Maintains accurate records and completes administrative and territory reports on time. .
• Prepares reports of business transactions and manages expenses within company guidelines.
• Investigates and resolves customer problems with deliveries.
• Attends trade shows, user groups and symposia.
• Estimates date of delivery to customer, based on knowledge of own firm’s production and delivery schedules.

Skills:
• Strong personal computer skills, including knowledge of Contact Management systems, Database Software and MS Office.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to effectively present information in one-on-one and small group situations to customers.

Education & Requirements:
• Bachelor’s Degree from four year college or university
• Two or more years related experience and/or training
• Capital experience preferred
• Must be able to travel up to 60% of the time
• Valid driver’s license

Territory: SD, ND, IA, NB, MN, N. WI

Have a good Science Knowledge…Looking to Enter Scientific Sales?  This is Your Opportunity! Wonderful Upside Potential, Great Benefit Package

 

Account Manager

Summary: Represents and sells company products and services; inclusive of all products where applicable.

 Job Duties:

• Required to meet company assigned sales objectives, inclusive of all  products where applicable.

• Travels throughout assigned territory to call on existing and prospective customers to solicit order.

• This includes on site visit to customers as applicable

• Maintains contact with customers by phone and/or e-mail when not on site.

• Displays or demonstrates product features and benefits, using all available and supported tools, and emphasizes salable features.

• Responsible to keep account activities and CRM up to date.

• Develops and maintains customer relationships with all pertinent account contacts.

• Sell Satellites to select market segments. This includes demonstrations of the instruments, if required, as well as the preparation of all financial and administrative documentation. Where applicable the Account Manager will sell Compacts.

• Work closely, and share information with, Sales Administration to ensure their ability to effectively handle the sequestering process for a designated percentage of “sequestering accounts” in the Account Manager territory.

• Prepares reports of business transactions and keeps expense accounts.

• Generates, qualifies and develops lists of prospective customers for use as sales leads.

• Investigates and resolves customer issues.

• Demonstrates excellence in understanding and selling “focus” products, which translates into achieving sales goals.

• Quotes prices and credit terms and prepares sales contracts for orders obtained.

• Estimates date of delivery to customer, based on knowledge of own firm’s production and delivery schedules.

• Attends trade shows and demos products.

• Serves as a model of excellence in sequestering and inventory management.

• Prepares reports of business transactions and manages expenses within company guidelines.

 Skills:

• Should have knowledge of Contact Management systems; Database software; Order processing systems. Spreadsheet software and Word Processing software experience required.

• Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Related Scientific/Technical Knowledge.

• Ability to learn to calculate reagent & control requirements for annual usage. Create instrument acquisition options including cash purchase, Reagent Rental and Cost per Reportable.

• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

Education & Requirements:

• High School Diploma or general education degree (GED) required; Bachelor’s degree (B.A) from a four year college or university preferred; Medical technology degree or MT Certification preferred; 1 to 2 years related experience.

• Valid Driver’s License.

• Must be able to travel up to 60% of the time.

Project Engineer – Field Service

Overnight travel up to 70% (90% including local travel) or as needed to complete responsibilities. Fulfill technical and field start-up responsibilities for all projects assigned by department supervisor. These include but are not limited to: technical sales support, design and ordering of support systems, review of system documents and drawings (mechanical, controls and validation), customer assistance, start-up of machine systems, training of machine users, preventive maintenance equipment reviews, rebuilds, site engineering evaluations and controls service minimum 5-7 years’ experience.

 

General Information: Bachelor of Science in Engineering, or equivalent/relevant experience. Experience with psychometrics, hydraulics, pneumatics, variable frequency drives, Allen Bradley PLC ladder logic and basic welding and metalworking. Familiarity with industry standards such as NFPA, NEC, and NEMA. Experience developing and interpreting control system drawings including P&ID’s, control system schematics, control panel layout drawings, and pneumatic and electrical interconnect diagrams. Knowledge of and experience in Microsoft Windows operating systems, Microsoft Office applications, and Microsoft Access and/or SQL Server. Confined space entry training maybe required for potential entry into confined spaces within supplied equipment. Must possess a valid driver’s license.