Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We offer a comprehensive benefits and a generous Paid Time Off package.
I. Position Overview:
The position is responsible for the design, schedule, execution, and evaluation of scientifically and statistically sound qualification experiments which define and demonstrate that critical Cleaning, Controls, Equipment, Facilities, Processes and Utilities function in a consistent and repeatable manner, and are in compliance with regulatory requirements, site procedures, product license restrictions, and policies affecting final product integrity. The position schedules activities involving manufacturing equipment to maximize equipment utilization, prepares detailed, concise documentation packages on completed studies that summarize the experimental results, specifications, and conformance to defined acceptance criteria, provides technical support to Business Development, Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs as needed. Assists the Validation department in developing policies, programs, SOPs, and Quality standards to meet current industry, internal Quality, and external Regulatory requirements.
II. Specific Duties, Activities, and Responsibilities: *
Validation empowered representative on cross-functional project teams.
- Validation Project Manager for cross-functional project teams.
- Researches governmental regulatory requirements on each assigned project to ensure that each study subject is challenged to meet required specifications.
- Prepares scientifically sound Validation Study Protocols that incorporate the defined specifications into acceptance criteria and assessment procedures.
- Schedules the execution of Validation studies with the appropriate department.
- Prepares detailed, concise documentation packages on completed studies that summarize the studies experimental results and specifications and their conformance to defined acceptance criteria.
- Maintains close contact with Business development, Engineering, and Manufacturing groups to assure effective communication on challenges and opportunities related to validation.
- Provides technical support to Business Development, Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs as needed.
- Assists the Validation department in developing policies, programs, SOPs, and Quality standards to meet current industry, internal Quality, and external Regulatory requirements.
- Supports the facility in internal and external inspections.
- Works directly with management, contract customers, and/or contract engineers.
- Maintain effectiveness of the Quality System components relevant to this position.
- Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
- Other duties as assigned.
III. Position Requirements: *
Education or Equivalent: *
- Bachelor of Science in Engineering or Science discipline preferred
- A minimum of one year experience in validation within a pharmaceutical manufacturing operation or three years experience in pharmaceutical operations.
- Knowledge of cGMPs, pharmaceutical manufacturing methods and validation principles.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to work independently on multiple projects.
- Be knowledgeable. Bring experience to the organization. Learn new skills; collect new information. Demonstrate a willingness to share skills and information with others.
- Demonstrate initiative. Develop ideas, and collect them from others. Continuously seek opportunity. Be detail oriented. Clarify issues, investigate
- Excellent documentation skills.
- Excellent problem solving and analytical skills.
- Full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred.
- High level of attention to detail.
- Make sound judgments. Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification. Act ethically.
- Meet deadlines and work under pressure with limited supervision.
- Must be able to interact effectively with a variety of individuals and personalities within and between departments.
- Possess and demonstrate excellent verbal, written and interpersonal communications skills.
- Should be familiar with cGMP and safe work practices.
- Strong Mechanical aptitude.
- Works well in a team environment.
- Works well under pressure and able to prioritize workloads.
- Demonstrated ability to read, write, and speak clear English.
- Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening
- Occasional bending, grasping, carrying, stooping, kneeling, crouching
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds
- Performance driven
- Customer focused
- Collaborative and inclusive
Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Job Type: Full-time