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.
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.
