Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Description:
The Specialist will be responsible for executing routine testing of complex and non-complex methods on intermediate and finished products, as well as environmental monitoring, utilities testing, and raw materials analysis as applicable.
This role also supports laboratory operations including housekeeping, reagent preparation, inventory management, and general lab maintenance activities.
Key Responsibilities:
- Executes routine testing of non-complex/compendial methods, environmental monitoring, utility testing, raw materials etc., as appropriate for the individual role
- Perform release/stability testing for complex and non-complex methods on intermediate or finished product
- Perform activities to support lab operations such as housekeeping, alarm acknowledgement, reagent preparation, inventory management, material and reagent ordering, sample pickup and discarding, and execution of work orders.
- May represent the department during regulatory inspections (or internal and external audits).
- Provides input into scheduling of assignments by the team lead / manager.
- Perform data verification and review
- Records performance metrics
- May update QC documents for managerial review and approval.
- May lead simple projects within the team. Also contributes to complex projects.
- May train colleagues in the execution of tasks and testing
- Contributes to change controls
- Supports deviation investigations and laboratory investigations through data gathering or interview process. May lead no impact deviations.
- Identifies and escalates challenges & barriers to execution, suggests solutions, and participates in remediation.
- Identifies and escalates method and/or instrument issues. Also supports and may lead solutions.
- Positive, supportive, and actively collaborates within the team.
- Actively and positively learns and participates in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team.
- Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).
- Perform other tasks as assigned.
Key Job Competencies
- Ability to understand and follow procedures.
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs.
- Attention to detail and demonstrate organizational skills.
- Ability to manage multiple assignments while meeting timelines.
- Knowledge of basic electronic systems (email, MS Office, etc.) and lab data systems (e.g. LIMS) required
- Ability to interpret and apply cGMPs, Compendia regulatory requirements and industry best practices.
- Excellent organizational and critical thinking skills.
- Is considered a fully independent analyst capable of executing tasks with no supervision
- Problem-solving ability/mentality, technically adept and logical.
- Ability to write technical documents
Qualifications:
- Bachelor’s Degree in a Scientific or relevant technical field with at least 1 year of experience, or a Master’s degree in a Scientific or technical discipline.
- Experience in pharmaceutical, biotechnology, or regulated environments is preferred.
- Strong ability to understand and follow procedures and work in a fast-paced team environment while meeting deadlines.
- Excellent communication skills (English/Spanish preferred), both written and verbal.
- Strong attention to detail, organizational, and critical thinking skills.
- Ability to manage multiple assignments and prioritize tasks effectively.
- Knowledge of laboratory systems such as LIMS and proficiency in MS Office applications.
- Understanding of cGMPs, compendial requirements, and regulatory standards.
- Ability to work independently with minimal supervision.
- Problem-solving mindset with strong technical and analytical skills.
- Experience in technical writing and documentation.
- Available to work extended hours if required.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
