Principal Validation Engineer

Description

Selkirk Pharma is seeking a Principal Validation Engineer to join our team. This position is primarily responsible for serving as a validation subject matter expert for qualification and validation of equipment, manufacturing processes and cleaning activities. This role leads and manages validation projects including validation strategies and executions in a GMP environment focused on aseptic parenteral drug product manufacture. The Validation Principle leads multiple complex validation projects and ensures documentation of the activities by Validation staff members and SMEs through procedures, protocols and reports to meet regulatory requirements. This role also develops validation strategies, reviews and approves validation documentation, leads diagnosis and resolutions of complex validation, process and equipment challenges. This position represents Validation on new product introduction teams and advises Validation colleagues on the latest approaches to risk assessments for processes and equipment use.

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

• Advise Validation staff on planning, organizing, writing and executing qualification and validation protocols and procedures and reports for equipment and processes. Provide department document approval.
• Serve as a validation subject matter expert for qualification and validation of equipment, manufacturing processes and cleaning activities.
• Lead high complexity validation projects including validation strategies, approaches, and execution.
• Act as Validation lead for new product introduction responsible for all validation activities including process validation.
• Develop validation strategies with internal stakeholders, including new equipment management and onboarding. Interface with external stakeholders and manage relationships.
• In partnership with the Quality Unit, lead efforts to resolve complex deviations.
• Work with cross functional teams to develop strategies to address change controls, investigations and CAPAs. Provide Validation input. Design and execute corrective actions. May serve as technical lead for investigations or change controls. Compile, analyze, and interpret data and information to support investigations, change controls, CAPAs, and risk assessments. Conduct literature searches and regulatory document reviews to provide technical assessments and advice.
• Lead risk assessments, gap analysis, product impact assessments, root cause analysis as needed. Advise Validation staff on the latest approaches to risk assessments for processes and equipment use. Work with Validation and Engineering staff to develop risk-based validation approaches and resolve complex validation issues.
• Lead diagnosis and resolution of complex validation, process and equipment challenges.
• Provide SME oversight as needed to Operations for engineering studies and machinability activities.
• Share knowledge and wisdom about good validation practices and lessons learned with Validation and other functions.
• Write and review technical documentation including SOPs, specifications, policies, procedures, work instructions, validation protocols and reports, and other documents as required.
• Advise and guide colleagues on writing validation documentation to conform with Selkirk’s validation policies and GXP standards.
• Drive continuous improvement in the quality of validation documentation.

We’re Looking for Someone who Has:

• Bachelor’s Degree in relevant discipline such as Biology, Chemistry, Engineering, or other related scientific discipline.
• Five (5) years of experience in a GMP, or regulated environment.
• Eight (8) 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.
• Five (5) years’ experience in a Validation role.
• Experience presenting and defending topics to external auditors around qualification and validation strategies.
• Experience with project management including leading groups and project teams with emphasis on strong communication skills, throughput and problem solving to accomplish objectives preferred.
• Extensive knowledge of 21 CFR Part 210 and Part 211, and Part 11. Knowledge of FDA cGMP, GAMP 5, Eudralex Volume 4 Annex 1, ASTM E2500, ICH, ISPE, USP, EP and other industry related guidance documents.
• Experience with technical and regulatory requirements for pharma or device manufacture in US and ex-US markets.
• Advanced technical understanding of Validation / Qualification Requirements and concepts as they apply to pharmaceuticals.
• Experience working in a manufacturing, CMO/CDMO, contract lab or direct client environment.

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

Hiring Wage: $107,000 - 120,000. See full list of benefits below for our complete compensation package.

Full Wage Range: $107,000 - 160,000. 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.