Validation Engineer

Description

Selkirk Pharma is seeking a Validation Engineer to join our team. This position is primarily responsible for writing and executing qualification and validation activities for equipment, cleaning, and manufacturing processes deployed in a GMP environment focused on aseptic parenteral drug product manufacture. In this role you are responsible for leading multiple validation projects and documenting activities to meet regulatory requirements. You will provide input to validation strategies, review validation documentation, advise colleagues on validation approaches, diagnose and resolve challenges with validation activities, conduct cleaning validation for new product introduction, develop re-validation and qualification strategies for equipment and processes, and lead risk assessments for processes and equipment use. As a Sr. Validation Engineer, you represent Validation in client project teams and intern project teams focused on introduction or changes to equipment or processes. You will work with your colleagues to drive incremental improvements to validation processes.

At Selkirk, our mission is simple: we want to be the world’s most reliable manufacturer of injectable drug products. As a new aseptic fill/finish contract manufacturer in Spokane, WA, every team member plays a critical role in helping us reach our vision of a world where safe and effective medication is accessible for every patient, every time it’s needed.

No matter your role at Selkirk Pharma, successful team members champion our values:

• Sincerity: We can work through anything if we are totally honest with ourselves and each other.
• Gratitude: So many good things come from gratitude: Dedication. Patience. Positivity. Kindness. We try to be actively grateful every day.
• Humility: To achieve greatness, we must be humble and self-aware in pursuit of our goals
• Enthusiasm: We intentionally bring an uncommon energy to every aspect of our work.
• Team: Our team is the nucleus around which everything else in our company is built.
  
  

What You’ll Do

• Plans, organizes, writes, reviews and executes qualification and validation protocols, procedures, and reports for equipment and processes.
• Advises and supports QC, Operations, Engineering, Metrology and Maintenance personnel performing validation activities. Provides expertise for routine qualification and validation activities.
• Leads low complexity validation project teams or client project sub-teams charged with executing validation activities.
• Conducts cleaning validation for new product introduction.
• Develops re-validation and validation strategies for current and new equipment and processes.
• Works with the Quality Unit to diagnose and resolve exceptional conditions and deviations per standard operating procedures (SOPs).
• Executes activities to address change controls, investigations and CAPAs under the direction of more senior staff.
• Leads risk assessments for processes and equipment use.
• Provides data for risk assessments, gap analysis, product impact assessments, root cause analysis as needed.
• Supports diagnosis and resolution of routine validation, process and equipment challenges.
• Uses knowledge management practices to assess lessons learned from validation activities, identify trends and share experiences.
• Writes and reviews technical documentation including SOPs, specifications, policies, work instructions, procedures, validation protocols and reports, and other documents as required.
• Advises and guides colleagues on writing validation documentation to conform with Selkirk’s validation policies and GXP standards.
• Understands and acts in accord with Selkirk’s Values in all interactions with Selkirk team members.
• Applies continuous improvement approaches to improve core skill areas such as cleaning validation, process validation, validation lifecycle and technical writing. Willing to constructively apply feedback to improve performance and generate ideas to improve and promote quality in work.
• Remains up-to-date on industry regulations, general GMP practices, validation practices, and trends.
• Shares industry knowledge with colleagues.
• Supports workplace safety, operational efficiency and facility compliance.
• Interacts with clients and regulatory authorities in audits and discussions supporting the facility, manufacture of client owned products and commercialization of client owned products.
  
  

We’re Looking For Someone Who Has

• Bachelor’s degree in science or engineering focus or other related scientific discipline.
• Five (5) years of combined experience in Validation (equipment, process, cleaning), Quality Engineering, or MSAT (manufacturing process, tech transfer) within the pharmaceutical, biotech, or medical device industry. Minimum of two (2) years of experience in a Validation role.
• Five (5) years of experience in a GMP, or regulated environment.
• Knowledge in 21CFR Part 201 and Part 211, and Part 11. Knowledge of FDA cGMP, GAMP 5, Eudralex Volume 4 Annex 1, ASTM E2500, ICH, ISPE and other industry related guidance documents.
• Experience working in a manufacturing, CMO/CDMO, contract lab or direct client environment.
• Proficient in the use of Microsoft Office Suite including: Word, Excel, PowerPoint, and Outlook.
• Experience utilizing LIMS software, ERP software, and QMS software.
• Working knowledge of electronic documentation systems such as DOT Compliance, QAD, PIMS.
• Experience with ERP systems such as SAP, PI.
  
  

This is an on-site, full-time, exempt position, located in Spokane, WA.

Hiring Wage: $80,000 - $99,000. See full list of benefits below for our complete compensation package.

Full Wage Range: $80,000 - $119,000. Midpoint and above is reserved for employees who have longevity with Selkirk and consistently exhibit outstanding performance over a period of time in the role.

What You’ll Love About Us

• Company Culture: Did someone say Taco Bar? As food fanatics, we like to find any reason to enjoy some good food together.
• Rest and Relaxation: 160 hours of PTO (pro-rated based on hire date), 52 hours of sick time (pro-rated based on hire date), and 10 paid holidays
• Bereavement Leave: 5 days per event
• Expand your Family: Paid Maternity/Paternity Leave – 160 hours per occurrence
• Health Benefits: Medical with HSA and FSA options, dental, vision, LTD, and Life and AD&D
• Employee Assistance Plan: Counseling sessions, legal services, financial services, and more
• Prepare for the Future: Stock options and 401(k) with no vesting period (100% match on the first 3% and 50% on the next 2%)
• When Duty Calls: Jury Duty that is. We offer up to 10 days per event.
• Cell Phone Stipend: $10 per month
  
  

Selkirk does not engage with recruitment services. All resumes / cover letters / applications / etc. sent to Selkirk are considered a direct application without representation. Selkirk does not compensate for recruitment services.