Pharma, Biotech, Medical Device - Multiple Openings, Nation wide

Multiple opportunities listed, please include position numbers or titles you are interested in the email subject.

Multiple positions are in multiple geographical areas (AZ, CA, CT, DE, FL, IL, IN, MA, MD, MN, NC, NJ, NY, OH, PA, PR, RI, WA). Some state needs to be listed for Monster posting needs.Experience level is 1 to 15 years as multiple positions. Candidates must be willing to travel, relocation is not necessary. If interested please reply with an updated resume in a MSWord format along with 3 references name, company email, company phone details to:

talent@pharma-biotech-talent.com

For all positions listed there is need for Quality Assurance personnel too with similar skills.

1. Computer System Validation Specialist
Excellent Provides Computer Validation Specialists, Technical Writers, Documentation Specialists with 21 CFR Part 11 compliance experience. Assessment of several computer systems(Manufacturing, Laboratory, network, application software). Work with system owners to explain the assesment and remediation plans. Perform gap analysis for Part 11 compliance. Perform Risk Assesments, create compliance deliverables.

Knowledge of FDA cGMP and related regulations and guidelines, specific knowledge of computer validation methodologies and principles. Experience in one or more of these applications:

·   EDMS (Documentum, QUMAS, Livelink)

·   ERP (JDE, SAP, Ross Systems)

·   Adverse Events (Argus, Oracle AERS, ARISg, Cerity)

·   IND Publishing (ISIToolbox, eCTDXPress, EZSubs, CoreDossier)

·   Laboratory Systems (Cyberlab, LabWare, Waters Millenium, Watson LIMS, SQL*LIMS, etc.)

·  Trackwise,Maximo, Clintrial, EZsub, Plateau.

2. Laboratory Equipment Validation
Excellent career opportunity for a Validation Specialist in Laboratory Equipment Validation Services addressing 21 CFR 11. Develop strategic approach and detailed plan for the remediation of all technical operations for non-chromatographic laboratory equipment. Should have experience with laboratory equipment and processes, 21 CFR 11, demonstrated large scale project management skills and excellent written and communication skills. Communication with management, clients, project team members and consultants. Ensure projects are completed on time and within budget. Provide schedule/time/resource input for proposals. Oversee compliance with quality standards.

3. Validation Consultants
Provide To do risk assessments and audits, GAP analysis, validation strategy development and planning, develop SOPs, protocols and reports, medical device (QSR), 21CFR Part 11. Provide regulatory guidance regarding CSV or Process and Equipment Validation procedures and cGMP, cGLP or cGCP. Generate system specifications, validation documents and CSV procedures. Perform on-site assessments, audits, risk analyses and client interviews. BS/BA degree in engineering, biochemistry or related field work experience in the pharmaceutical industry and QA area. Knowledge of Computer System Development Life Cycle (SDLC) requirements and FDA regulations, GxPs, and experience with validation of automated processes and equipment.

4. Process and Equipment Validation
Provide Consulting Services within the FDA regulated industries nationwide. Must have experience in a pharmaceutical setting providing equipment qualification and process validation services. If you have experience with mixers, HVAC, WFI, Purified Water, Temperature Mapping, Autoclaves, Freeze Dryers, Cleaning Equipment or Plant Facilities Validation.

5. LIMS Validation
Provides Consulting Services within Responsible for writing OQ and PQ test scripts for new functionality and modifying existing test scripts. Responsible for managing documents in the corporate document management system. In addition you will also be responsible for running test scripts, documenting errors and suggesting corrective actions.

·  Experience with lab management proceses, applications, and databases (SQL*LIMS, Labware, Watson, LabManager, Sample Manager, Nugenesis, Empower, other LIMS applications) validation Test Script writing.

6. ERP Validation Consultants
Multiple person requirement for ERP / SAP Validation Consultants.

Functional consultants with testing background are also acceptable. Strong experience with writing and executing validation plans, generating and executing test scripts and protocols, conducting testing, and preparing final summary reports. SOP writing experience preferred.

7. SAP Functional Consultants
Candidates with experience in any of the modules -- FI, SD, MM, HR, PM, PP, PS, QM. At least 2 years of experiene in SAP Implementation.  Excellent verbal and written communication skills. SAP certification will be an added advantage.

8. EDMS Validation Consultants
Candidates must have specific hands-on computer validation experience with any EDMS package. Hands-on SDLC methodology experience in Computer Validation in FDA related industry. Demonstrated experience is required in writing, reviewing and executing computer validation documentation and performing software testing and computer validation on EDMS applications and systems. Candidate must have working knowledge of 21 CFR Part 11 and cGMP regulations.

9. Software Application Testers
Candidate will work from Functional Specifications, Requirements & Use Cases to create test plans / strategy and test cases to perform manual testing of a web based application and web portal.

To be considered for this role, you must have experience with the following: Strong manual data tester who can create test plans, test cases and an overall testing strategy and then create/execute reusable test scripts for software applications.

This is a hands on planning and execution role that requires a person be very detail oriented, self motivated, and organized to manage multiple projects. Should be able to read SQL statements and understand how to create negative test and integration testing . Should understand Configuration/Release management as it relates to the development lifecycle.

All positions require the following skills:Experience working in FDA regulated environment is preferred. Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Excellent communication skills. Ability to work as a team player in a consulting environment. With a willingness to travel, relocation is not necessary. For direct and contract positions. Must be willing to work extended hours (overtime is paid for). Proficiency with MS Office tools Documentation management

KEYWORDS: Quality, Quality Assurance, Quality Control, Remediation, Document Control, Validation, Investigations, Pharmaceuticals, Biotech, Manufacturing, Contracting.

10. Sales Professional - Account Manager

Sales Professional to service this geographical region or other parts based on your location. This is a spectacular opportunity for an entrepreneurial person to rule a region as an individual contributor. We can offer you the opportunity to grow your career with a consulting company in the regulatory compliance industry and become a highly visible member of the sales team. We offer Base + High Commission structure with no cap. We offer Base + High Commission structure with no cap. If interested in any of the above positions please reply with an updated resume in a MSWord format to: 3+ years front line sales experience in life sciences sector (pharmaceutical, biotech, medical device). Experience selling consulting services preferred.  Seeking candidates with experience selling large scale multi-year contracts. Ability to work independently, from a home office or company office. Results oriented.  Ability to apply creativity to overcome obstacles. 

If interested in any of the above positions please reply with an updated resume in a MSWord format along with 3 references name, company email, company phone details to: talent@pharma-biotech-talent.com

Candidates possessing valid visas (F1 or L1 or wanting to do H1B transfers) will also be considered if also sending 3 references. We offer excellent benefits and great career path.
Please no phone calls. If your skills match the required above, our representative will contact you. Due to high volume of submissions, if your resume does not meet the required skills, you will not be contacted.