What are the responsibilities and job description for the Validation Manager position at Alcami Corporation?
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BE PART OF AN ORGANIZATION WORKING WITH COMPANIES WHO ARE FINDING CURES AND TRANSFORMING MEDICINE!
Full-time hourly position - competitive salaries, career advancement opportunities, a bonus plan, excellent benefits package including a matching 401K, health, dental, vision and tuition reimbursement.
Job Summary
Plan, schedule, coordinate and track facets of the validation team and validation projects including, but not limited to, determining quote factors with customers, approving quotes, establishing project pricing, allocating manpower, direct, support and oversee testing efforts; execute, review or approve protocols for Validation testing on equipment, utilities or computer systems. Process, assemble and review data, generate documentation and reports. Coordinate multiple tasks at one time. Coordinate the efforts of the validation team and delegate tasks to staff as necessary. Provide assessments and reviews of direct reports. Provide training and supervision to staff. Foster best practices and efficiencies resulting in satisfied customers and competent staff. Keep current in changes in industry.
Coordinate the efforts of the validation team, and any assigned field metrology team members, and delegate tasks to staff as necessary. Provide assessments and reviews of direct reports. Provide training and supervision to staff. Foster best practices and efficiencies resulting in satisfied customers and competent staff. Keep current in changes in industry
Essential Duties and Responsibilities
- Perform pre- and post-validation verification on test equipment
- Perform calibrations incidental to the validation including controllers, gauges, recorders, etc.
- Create and execute validation protocols, procedures, work instructions, and final reports
- Schedule, lead, and perform validation projects
- Perform peer review of validation reports; approve validation final reports, as needed
- Execute troubleshooting strategies in the field
- Maintain records of pertinent information for the project including project costs reconciliation
- Evaluate, interpret and give opinions on validation or calibration results - relay opinions and suggestions to clients
- Independently manage technical writing and documentation aspects of validation reports
- Write and work with clients to resolve deviations and complaints
- Troubleshoot, evaluate and document the project and team members performance to improve processes
- Work with the Sales department to meet with new and existing clients periodically to support business development
- Independently execute sterilizer qualification work and steam quality testing
- Attend management-approved, external training events
- Work with Finance department regarding project related billing activities
- Participate in problem management activities such as developing and implementing corrective actions
- Participate in change management
Education, Experience and Qualifications
- BA/BS in technical or science related field of study. Candidates with an HSD/GED, technical training, or an Associate's degree combined with mechanical aptitude or relevant industry experience are also encouraged to apply
- Seven years of direct validation experience
- 3-5 years supervisory or project management experience
- Advanced knowledge of MS Word and Excel
- Proficient with test instruments
- ISO 9001, ISO 17025, GMP and GLP knowledge
- Independence and strong background in sterilizer validation preferred
- Excellent verbal and written communication skills
- Team building and problem-solving skills
- Excellent reporting, organizational and interpersonal skills
- Business analysis skills
- Experience in temperature mapping
Additional Information
- Drug testing
- Inoculations specific to customer sites
- Travel required
- Valid driver's license
What We Offer You:
* Competitive salary with career advancement opportunities
* Bonus plan
* Medical, dental and vision coverage from day one
* 401(k) with company match
* Company paid vacation, holiday and sick-leave
* Voluntary benefits including short & long-term disability, life, accident, critical illness insurances
Diversity and Inclusion:
Alcami values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
