Company Description
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
Job Description
Our client requires a Utilities/Facilities Validation Consultant for a 6-month, on-site engagement at their Ottawa ON, CA facility. Our client is looking for those with mechanical or electrical/automation engineering backgrounds. Duties and responsibilities to include, but are not limited to:
Define draft Maintenance Procedures and Schedules with consultation from Original Equipment Supplier/Vendor, including the As-Built DWG’s (PID, Schematic DWG’s, Detailed DWG’s, maintenance manuals, user manuals …etc.)
Verify draft maintenance procedures in the field and update accordingly.
Review documents with approvers/owner and update based on feedback received.
Facilitate approval of documents to then be entered into BMRAM (Blue Mountain Regulatory Asset Manager)
Additionally, obtain Supplier Operation & Maintenance (O&M) Manuals and evaluate recommended Spare Parts List for 1-Year and 2-Years.
Support the creation of item masters and applicable specifications of recommended spare parts
Item masters – internal client form that allows the part to be entered into oracle so that they can be inventoried and ordered
Specification – critical spare part may require incoming inspection to receive an inventory the parts. The specification will outline the sampling plan and what would need to be verified to accept and inventory the part.
Qualifications
Qualified candidates will possess a Bachelor’s degree in related field along with 5 plus years related industry experience.
Candidates must have excellent verbal communication and technical writing skills.
Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
Familiarity with many aspects of validation is expected.
Experience with temperature mapping.
Proficient in Microsoft Word, Excel, Power Point and Project.
Must be willing to travel regionally and/or nationally throughout the US.
Additional Information
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***