Process Engineers and Validation Engineers / Specialists

Pharmaceutical Validation Solutions, Inc. offers comprehensive knowledge of current regulatory standards, practices and a unique awareness of enforcement policies and activities. Our principle goal is to assist food and drug manufacturers in assuring compliance with current regulatory needs. Our work includes in-house validation and engineersing support, review of validation efforts and documentation, writing and review of SOPs, and auditing all areas of manufacturing and research. Founded in 2001 and privately held, Pharmaceutical Validation Solutions, Inc. is headquartered in Middleburg, Pennsylvania, and is aggressively recruiting to meet the growing demand for its services for satellite offices in metro Boston and central New Jersey .


Pharmaceutical Validation Solutions, Inc. is a rapidly growing comapany and we have exciting opportunities for Process Engineers and Validation Engineers / Specialists to join our Teams in the Greater Philadelphia, New Jersey and New England areas. 

Scope:

Our Top Tier Pharmaceutical Clients in the Greater Philadelphia, New Jersey and New England areas have opportunities for experienced Process Engineers and Validation Engineers / Specialists to perform full lifecycle engineering and validation activities. 

Process Engineers / Specialists

 

OVERALL RESPONSIBILITIES:

? Provide Engineering Leadership and Project Management for the Development and Launch of Biomaterial Implants of a Ceramic, Polymeric, and Metallic Nature.

? Implement Just-In-Time (JIT) or Lean Manufacturing Principles to Cleanroom Manufacturing Operations.

? Design and conduct process development studies to troubleshoot problems, introduce new equipment and manufacturing lines, process scale-up, and new product introduction.

? Generate required documentation (Validation Protocols, SOP?s, Device Master Records, Maintenance/Calibration Procedures) to manufacture new products, use new procedures or introduce new equipment to the manufacturing operation.

? Responsible for the identification, procurement, installation, and validation of process related equipment.

? Responsible for validating new processes or new product manufacturing procedures.

? Other Duties as Assigned.

 POSITION DUTIES & RESPONSIBILITIES:

? Active Project Management and Technical Leadership Responsibility for projects related to New Product Introduction of Biomaterials.

? Periodically evaluate production operations for potential improvements in quality, efficiency, and cost reductions.  Insure products are manufactured in accordance with specified requirements.

? Train manufacturing personnel in changes implemented to manufacturing operations.

? Provide technical assistance to Quality Assurance and Regulatory Compliance personnel in regards to new products, processes, and procedures.

? Provides other project or product support as needed in order to support Norian?s and/or Synthes? business demands.

 

PROFESSIONAL EXPERIENCE REQUIREMENTS:

 

? 5-10 years experience in a cleanroom environment (Class 100,000 or better) supporting new product introductions and troubleshooting problems for existing products.

? Experience with ceramic manufacturing processes within the medical device industry desired,(i.e bone void fillers, restoratives, cements).

? Processing experience in powder conditioning and processing, solid state reactions, sintering, milling, and emulsification processes.

? Experience in developing Just-In-Time/Lean manufacturing processes, including forecasting, capacity analysis, cell layout and man/machine balances.

? Project Management Experience including familiarity with project software.

? Proactive approach to tasks and sense of urgency for their completion

? Ability to work effectively within a team environment to resolve problems and implement change

? Ability to meet deadlines and multitask in a fast paced environment

? Experience with small to medium scale medical device packaging.

? Knowledge of validation fundamentals, statistics and process capability

? Involvement with the implementation of  a preventive maintenance program

? Familiarity with Office applications (Word, Excel, PowerPoint)

? Organizational Skills, Data Management, Effective Communication, High Attention to Detail & Accuracy. 

 

EDUCATIONAL REQUIREMENTS:

? Bachelor of Science in Chemical, Ceramic, Biomedical, or Industrial Engineering,; Chemistry or Material Science.

 

OTHER REQUIREMENTS:

? Familiarity with Statistical Software (Minitab, Statgraphics, or equivalent)

? Familiarity with 2D or 3D Drafting Software (Pro-Engineer, AutoCAD, etc?)

Validation Engineers / Specialists

 Responsibilities will include: Writing and executing IQs, OQs, PQs and Change Controls for various validation contracts. Experience in working with HVAC, utilities, CIP, SIP, bioreactors, chromatography, filtration, Kaye Validators, refrigerators, freezers, incubators, cold rooms, autoclaves, HPLC's, QC lab equipment, process, cleaning, computer, ERP and/or LIMS validation.

Requirements:

BS/BA Preferred.2 - 10 + years of experience.Strong written and oral communication skills.Capable of writing validation protocols and technical reports to support study objectives.Capable of presenting validation issues and results to management and clients.Good interpersonal skills.Capable of interacting with Laboratory, Quality, Development, Manufacturing and Engineering personnel for the coordination of validation studies and resolution of issues.Proficient in software relating to the writing of validation documentation an data analysis/reporting.Strong understanding of manufacturing methods, equipment and controls for production of bio-pharmaceutical equipment and processes.Knowledgeable in current Good Manufacturing Practices. FDA guidelines and DEA regulations.Good problem solving ability and analytical thinking.Capable of independent work.

 

For immediate consideration, send a word formatted version of your resume to: employment@pvsinc.com

1099 and W2 hourly arrangements are all welcome!

Pharmaceutical Validation Solutions, Inc.'s Recruiting Team looks forward to speaking with you.