Facilities & Engineering Investigation Writer at Leiters Inc

Englewood, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Oct, 26

Salary

92000.0

Posted On

13 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Root Cause Analysis, Technical Writing, cGMP Compliance, SOP Development, Data Trending, Asset Management, Statistical Inference, Microsoft 365, CMMS, USP Guidelines, 503B Regulatory Requirements, Pharmaceutical Manufacturing

Industry

Pharmaceutical Manufacturing

Description

The Facilities & Engineering Investigation Writer reports to the Vice President, Facilities and Engineering and is responsible for leading critical investigations, transforming findings into actionable solutions, and helping strengthen the systems, equipment, and processes behind sterile pharmaceutical manufacturing. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. * Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. * Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives. * Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. * Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. * Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions and Responsibilities: * Lead and support prompt and thorough investigations assuring that thorough root cause evaluations are performed in compliance with cGMPs and associated SOPs and ensures timely closure for each investigation as well as follow-up activities. * Work with the functional areas to identify the most probable root cause(s) and determine appropriate preventive and corrective actions. * Trend and analyze investigation data and address appropriately in cooperation and collaboration with other support functions such as Quality, Operations, and Technical Services. * Supports and maintains an environment that fosters communication and teamwork within the F&E Team and other departments. * Write technical documents to support F&E including SOPs and Work Plans. * Train and mentor less qualified employees in the department. This includes but is not limited to processes, procedures in compliance with established protocols and regulatory guidelines. * Maintain current knowledge of cGMPs through appropriate training programs. * Share operational knowledge with peers, new-hires, contingency staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance. * Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business. * Ensure asset management program equipment and instrument data is accurate through routine auditing or proper data integrity. * Other duties as assigned. Experience and Necessary Skills: * Bachelor's degree with a minimum of 2 years of relevant experience in the pharmaceutical industry preferred. * CMMS and facilities experience preferred. * Detail oriented. * Ability to work with mathematical concepts such as probability and statistical inference. * Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. * Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines required * Proficient written, verbal and oral English communication skills are required. * Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel. Physical Requirements: * Ability to stand or sit for extended periods of time. * Ability to lift, push and pull up to 50 pounds periodically. * Ability to work majorly on-site. Benefits: * Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!) * Flexible Spending & Health Savings Accounts (FSA & HSA) available * Dental & Vision insurance * Employer Paid Life Insurance & Employee Assistance Program * Short Term & Long-Term Disability Insurance * Up to 4% 401K Matching (100% vested on day one!) * Generous Paid Time Off Options – vacation, sick, paid leave and holidays! * $5,250 Annual Tuition Reimbursement after 6 months * $1,000 Referral Bonus Program with no limit * Eligible for annual bonus program    Timeline: We will be accepting applications on an ongoing basis until position is filled.  We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.

Responsibilities

Lead and support critical investigations to identify root causes and implement corrective and preventive actions in a sterile pharmaceutical environment. Write technical documentation, including SOPs and work plans, while mentoring junior staff to ensure cGMP compliance.