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Senior Commissioning & Qualification Engineer – Automation (Biopharma Build)
Owner’s Representative | Onsite – Spring House, PA
Contract through end of year, potential for ongoing extensions
We are seeking a senior Commissioning & Qualification (C&Q) Automation SME to support the delivery of a state-of-the-art Cell & Gene Therapy manufacturing facility.
This is a high-visibility, onsite role where you will serve as the Owner’s Representative, ensuring highly automated GMP process systems are properly commissioned, integrated, and inspection-ready. If you thrive in complex, automation-heavy capital projects, this is the type of build that defines careers.
What You’ll Be Doing
- Act as the technical SME for commissioning automated process equipment
- Represent the owner’s interests across all project phases
- Lead execution of Commissioning Plans with emphasis on automation, integration, and data integrity
- Author and review IQ/OQ/PQ protocols, URS, and validation documentation
- Oversee startup and field execution for complex equipment platforms
- Drive resolution of automation-related deviations and integration issues
- Coordinate across automation, construction, validation, quality, and vendor teams
- Apply risk-based qualification principles (ASTM E2500, FMEA)
- Ensure compliance with GMP, FDA, and 21 CFR Part 11
- Support digital validation platforms (e.g., Kneat)
Equipment & Systems Scope
- Cell & gene therapy manufacturing systems
- Fill/Finish lines
- Isolators
- Integrated process equipment platforms
- PLC / SCADA / DCS automation layers
What We’re Looking For
Required:
- Bachelor’s degree in Engineering or Life Sciences
- 5–10 years of CQV experience in automated biopharma manufacturing
- Hands-on experience with process equipment and control systems
- Strong understanding of GMP validation lifecycle
Strongly Preferred:
- DeltaV, Rockwell, Siemens, or similar DCS/PLC platforms
- Experience in greenfield or large capital projects
- ASTM E2500 / GAMP 5 knowledge
- Experience with digital validation tools (Kneat, Veeva)
- Background in cell & gene therapy, fill/finish, or cleanroom environments
Why This Role?
- High-impact, automation-heavy greenfield project
- Owner-side authority and visibility
- Complex, integrated GMP systems
- Opportunity to shape commissioning strategy at a flagship facility
EEO Statement:
- Eight Eleven Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.
About the Company
Our client a nationally recognized specialty electrical contractor is currently seeking a Senior Electrical Estimator
The Senior Electrical Estimator is a position that supports our clients fast-growing High Voltage Substation, Electrical Construction and EPC businesses. This position will participate in pre-bid meetings and bid proposal development. This role handles contract aspects during both the tendering and project initiation phases for assigned projects. The Senior Estimator will provide analysis of customer specifications, requests for quotations, material pricing and all related commercial, legal and technical documents for business opportunities. This position will actively participate in the project hand off process and assist during project commencement. This position may lead a team of junior estimators and mentor other staff. This position may require limited overnight travel.
About the Role
Responsibilities:
- Experience estimating 35kV – 500kV air insulated and gas insulated switchgear and substations
- Review and analyze customer specifications and bid documents in order to identify potential constructability, commercial and legal risks
- Attend pre-bid meetings and site visits. Document notes and photos.
- Review, analyze and identify inconsistencies in the drawings. Determine the need for scope clarifications and submit scope clarifications as needed.
- Solicit subcontractor and vendor pricing
- Provide cost estimates for substation proposals
- Develop bid clarifications and exclusions for the bid submittal. Address identified risk points and gaps in scope
- Participate in constructability reviews and cost saving enhancement discussions
- Work with the estimating and projects teams in order to develop a resource loaded schedule to include with bid submittals
- Lead the project hand off process by preparing the package of drawings, estimate and other supporting documents needed for review with operations for successful project execution.
- Participate in the estimate review process with leadership
- Prepare and/or provide input for customer required deliverables (schedule, proposal letter, etc.)
- Develop scope of work packages for subcontractors and analyze subcontractor proposals.
- Maintain and enhance customer relationships.
- Prepare proposal submittals.
- Prepare estimates and various other legal documents for signature and assist with the drafting and preparation of proposals.
- Assist in the preparation and facilitation of internal risk review meetings;
- Assist the businesses in determining prime contract flow down terms and conditions for incorporation into supplier and subcontract agreements and ensure internal departments know HR/insurance requirements;
- Assist Project Managers with change order preparation;
- Travel to project and bid locations as needed.
Qualifications
- 7+ years of HV Substation estimating experience in the Electric Utility, Transit or EPC Markets
Required Skills
- Proficiency in reading and understanding project documents and drawings
- Exceptional oral and written communications
- Ability to analyze and identify basic and complex commercial and contractual risks
- Proficient Negotiation Skills
- Proficient in MS Office, MS Project and Procore
Pay range and compensation package
- $140,000 - $200,000 plus bonus
- Mon - Fri 8am - 5pm
- Average 24 patients per day
- Outpatient clinic
- Full scope OB/GYN clinic coverage
- Surgery capability preferred
- We negotiate better pay and deposit it weekly
- We arrange complimentary housing and travel and comprehensive malpractice coverage
- We simplify the credentialing and privileging process
- Access to online portal for assignment details and time entry
- Your specialized recruiter takes care of every detail
CompHealth started in 1979 with the idea of connecting top healthcare providers to the communities who need them and has since become the industry leader in healthcare staffing. Connecting with each person?s unique story in order to find them the right job for their lifestyle is what makes us different. And with 1,000 employees in offices across the nation, we have the team in place to ensure that every provider and facility staff recruiter receives the excellent customer service we?ve offered for nearly forty years. Learn more at so we can find the job that?s just right for you.
Company: Fusion Medical Staffing
Location: Facility in Sellersville, Pennsylvania
Job DetailsFusion Medical Staffing is seeking a Med Surg/Tele RN for a 13-week travel assignment in Sellersville, Pennsylvania. As a member of our team, you'll have the opportunity to make a positive impact on the lives of patients while enjoying competitive pay, comprehensive benefits, and the support of a dedicated clinical team.
Required Qualifications:- One year of recent Med Surg/Tele RN experience
- Valid RN license in compliance with state regulations
- Current BLS (AHA/ARC) Certification
- NIHSS certification
- ACLS (AHA / ARC) certification
- Other certifications and licenses may be required for this position
The Med Surg/Tele Registered Nurse delivers comprehensive high-quality, patient-centered care in medical-surgical and telemetry units. This role involves assessing patient health conditions, monitoring cardiac telemetry data, and collaborating with multidisciplinary teams to manage diverse patient needs. The position requires strong clinical skills in med-surg and telemetry nursing, critical thinking abilities, excellent communication, and a commitment to maintaining the highest standards of patient safety and professional ethics.
Essential Work Functions:- Explain procedures and treatments to patients and families, addressing concerns and ensuring understanding
- Administer prescribed medications and treatments in adherence to nursing standards
- Conduct comprehensive assessments of patients' conditions, documenting changes and reporting concerns to the care team
- Prepare patients for diagnostic procedures, assist physicians during treatments, and monitor patient responses
- Maintain a safe and comfortable environment for patients recovering from medical conditions or surgical procedures
- Document comprehensive patient information, including vital signs, medications, treatments, and care outcomes, in the medical record
- Collaborate with interdisciplinary teams, including physicians, physical therapists, and social workers, to create and implement individualized care plans
- Manage multiple patients efficiently, prioritizing care based on acuity and clinical needs
- Ensure infection control practices are strictly followed, including hand hygiene and PPE use
- Advocate for patients' needs and preferences, ensuring they are respected and integrated into the care plan
- Facilitate discharge planning, coordinating with patients, families, and external resources to ensure a smooth transition from hospital to home
- Perform other duties as assigned within the scope of practice
- Adhere to hospital safety protocols, infection control guidelines, and regulatory standards
- Critical thinking, service excellence, and good interpersonal communication skills
- The ability to read, write, and communicate in the English language
- Ability to read/comprehend written instructions, follow verbal instructions, and proficiency in PC skills
- Physical Abilities - Must be able to remain in a stationary position, move about, move equipment (50-100lbs), push, pull, and bend
- Interpersonal Skills - Must be able to work effectively with a variety of personnel (professional and ancillary) to present a positive attitude and professionalism
- Technical/Motor Skills - Must have the ability to grasp, perform fine manipulation, push/pull, and move about when assisting with procedures and/or using department equipment
- Mental Requirements - Must be able to cope with frequent contact with the general public and customers while meeting deadlines under pressure. Must be able to work under close supervision occasionally, as well as working without assistance from other personnel. Must be able to contend with irregular activity schedules occasionally and continuous concentration to detail
- Sensory - Must possess visual acuity and ability to effectively communicate
- Highly competitive pay for travel professionals
- Comprehensive medical, dental, and vision insurance with first day coverage
- Paid Time Off (PTO) after 1560 hours
- Life and Short-term disability offered
- 401(k) matching
- Aggressive Refer-a-friend Bonus Program
- 24/7 recruiter support
- Reimbursement for licensure and CEUs
At Fusion Medical Staffing, our goal is to improve the lives of everyone we touch, and we're always looking for people like you to join our mission. Your passion for helping others deserves a partner just as committed to supporting you - that's why we offer day one insurance, $0 copay for mental health services, scholarships and awards, exclusive discounts, and more. From your personal recruiter to our clinical and traveler experience teams, we're here to guide and celebrate you along your journey. You take care of others; we take care of you.
Other Duties Disclaimer:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other duties may be assigned. This job description is not a comprehensive list of all activities, duties, or responsibilities that are required of the employee for this job and is subject to change at any time with or without notice.
Start your rewarding career as a Travel Med Surg/Tele RN with Fusion Medical Staffing and join our mission to improve lives. Apply now!
Fusion is an EOE/E-Verify Employer
Job Title : Medical Assistant/Technician (Hospital Corpsman) Category / Component : Enlisted • Both Overview Hospital Corpsmen assist healthcare professionals and provide medical and dental care to Sailors, Marines, and their families across clinics, hospitals, ships, and field units, gaining broad clinical, technical, and operational experience.
Key Responsibilities Perform emergency medical treatment for Sailors, Marines, and specialized units such as SEALs and Seabees; provide basic and emergency dental care and process dental X rays; serve as operating room technician and assist in surgery; administer preventive care and medications including immunizations and IVs; conduct physical exams and assist in diagnosing and treating diseases and injuries; maintain patient records, perform clinical tests, and support physicians and nurses in a wide range of specialties.
What to Expect Hands on patient care with shift work and possible on call duties; field training and deployments with Marine and expeditionary units and embarked medical departments on ships; continuous certification and recertification in areas such as basic life support, trauma care, and tactical combat casualty care; mix of clinic, ward, and field environments with rapid response in emergent situations and a strong emphasis on teamwork and readiness.
Work Environment Assignments in Navy hospitals and clinics, aboard aircraft carriers and other ships, with Marine units in garrison and field environments, and occasionally on submarines; work in exam rooms, wards, operating rooms, emergency departments, aid stations, and field medical sites; close integration with medical teams, line units, and joint or coalition partners.
Pathways, Training & Advancement Recruit Training followed by Hospital Corpsman A School at Fort Sam Houston, Texas; numerous advanced C schools that lead to Navy Enlisted Classifications in areas such as Independent Duty Corpsman, Fleet Marine Force, preventive medicine, surgical technology, respiratory therapy, pharmacy, radiology, laboratory, dental, and dive medicine; progressive professional development through leadership courses and warfare qualifications such as Fleet Marine Force and Surface, Aviation, or Expeditionary pins where applicable.
Direct enlistment into the Hospital Corpsman rating from civilian life; in service conversion for qualified Sailors from other ratings who meet screening and performance criteria; Reserve accession for prior service Hospital Corpsmen and select civilian medical professionals when manning needs allow.
Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.
Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.
Additional qualifications for this job may include: United States citizenship or equivalent status as allowed by policy; high school diploma or equivalent; at least 17 years of age; interest in healthcare and willingness to work in clinical and field environments, potentially under stressful conditions; ability to meet medical, vision, and physical fitness standards required for medical and operational assignments.
Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.
Specific options depend on the Sailor's status, training, and current Navy policy.
Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.
Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.
Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.
Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.
Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.
It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.
Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.
Earn big and work on your own time and terms as a Grubhub delivery partner! Grubhub is looking for drivers and bikers like you to hit the road quick and start delivering from restaurants, liquor stores, convenience stores, and more. Looking for a flexible way to earn extra cash? Grubhub is the gig for you.
Why deliver with Grubhub?
- Earn competitive pay and keep 100% of your tips from completed deliveries
- Create your own flexible schedule to work when you want
- It's easy to get started, with no resume, interview, or experience required
- Get paid instantly with Instant Cashout
All you need to get started is:
- A car (or scooter/bike in select areas)
- Valid driver's license and auto insurance for drivers
- Valid driver's license or state ID for bikers
- Smartphone (with a data plan)
Ready to hit the road? Download the app to get started!
All drivers must also be at least 18 years of age (21+ in Las Vegas). Grubhub delivery partners are independent contractors, not employees of Grubhub.
Remote working/work at home options are available for this role.
Our client, a well-established, pharmaceutical organization is hiring an Associate Director of Manufacturing Quality Assurance with the opportunity to grow in a specialized manufacturing facility. The ideal candidate has:
- Pharmaceutical Manufacturing Experience (in oral solid dosages)
- Supporting manufacturing from the quality perspective
- An understanding of quality on the floor or experience working on the floor
This role will be a leader in an organization that continues to grow and establish themselves as a global leader. Responsibilities include, but are not limited to:
- Support the continuous improvement of manufacturing quality systems and processes.
- Provide QA oversight for all manufacturing operations
- Review and approve manufacturing batch records, line clearance documentation, and associated QA forms.
- Train and mentor QA personnel and manufacturing operators on quality-related topics.
- Oversee and (commonly) author investigation of manufacturing deviations, non-conformances, and out-of-specification (OOS) results.
The ideal candidate would have 8–10 years of progressive experience in pharmaceutical manufacturing quality assurance or quality systems.
This role does require relocation to the facility located in the Midwest.
JOB DESCRIPTION
The Research and Development Operator I would operate, clean, disassemble, and reassemble equipment such as blending, granulation, compression, and coating machinery in accordance with applicable cGMP and SOPs. In this role, the incumbent would rotate between Pilot Plant and Manufacturing departments as determined by the needs of the business.
Essential Duties & Responsibilities
- Proficiently operate, disassemble, assemble, and clean equipment.
- Operate, disassemble, assemble, and clean equipment in other departments proficiently.
- Routinely perform housekeeping assignments, maintain cleanliness and routine maintenance of the work area and equipment.
- Uses computer to read, review, and train on SOPs.
- Review current SOPs and provide feedback on potential process improvements.
- Participate in work scheduling. Handle computer transactions/metrics for the department.
- Record operating data within batch records in accordance with cGDP.
- Review and record completed production documentation (batch records, logbooks, etc.) for quality and cGMP compliance.
- Able to troubleshoot production processes and notify applicable parties for assistance.
- Recognize and report manufacturing incidents. Support investigations and support CAPA’s on occasions.
- Builds productive, trusting, and respectful relationships at all levels in the organization and must consistently act as a team player.
- Collaborate effectively and communicate with other functional groups, including quality, validation, and supply chain to ensure production goals are achieved.
- Follows Piramal Pharma Solutions Safety, Health, and Environmental policies and procedures.
- Maintain confidentiality for all clients and activities in the development process.
- Performs other duties as assigned or as business needs require.
Requirements
- High school diploma or GED required.
- Individuals with equivalent education, training, and experience will be considered.
- Experience in a pharmaceutical, chemical, biochemical, or food manufacturing environment required.
- 2+ years working within an industrial or manufacturing environment preferred.
Physical Requirements
- Lift up to 40 lbs. and occasionally move drums weighing up to 300 lbs.
- Able to work safely with heavy equipment.
- Regularly stand, walk, sit, use hands to finger, feel objects, tools, controls, reach with hand and arms, talk, hear, and good vision.
- Ability to climb ladders, bend, stoop, and kneel.
- Individual may be required to wear Personal Protection Equipment including N95 respirators and Powered Air Purifying Respirators.
- Not allergic to chemicals or bio-substances found in laboratory or production facilities.
Duration: 12 months
Description:
QA Shop Floor - 3rd shift
Must be able to work four 10 hour days, Sun to Wed 9:30pmEST to 8:00AMEST or
Wed to Sat: 9:30pmEST to 8:00AMEST
Responsible for maintaining quality records, assisting with corrective action plans, and supporting quality system improvements. You will collect and organize data, prepare reports, and ensure inspection readiness while addressing routine quality inquiries.
Key Responsibilities
- Collaborate with cross-functional teams to implement innovative quality assurance protocols on the shop floor, ensuring seamless production flow and minimal defects.
- Utilize data-driven insights to proactively identify potential quality issues and develop creative solutions to enhance product reliability.
- Engage in hands-on inspection of products, applying a keen eye for detail to uphold stringent quality standards.
- Performs batch records review and cleaning records review to ensure product availability.
- Support work orders review and confirm area cleanliness after maintenance interventions.
- Performs area walkthroughs to ensure audit readiness at all times.
- Contribute to continuous improvement initiatives by suggesting and piloting novel QA methodologies tailored to dynamic manufacturing environments.
- Document and communicate quality findings through clear, concise reports that facilitate swift decision-making and process optimization.
- Maintain accurate and timely quality records related to product inspections, nonconformance, and project outcomes.
- Assist in documenting, monitoring, and following up on corrective and preventive action plans to ensure their effective implementation and closure.
- Respond to routine inquiries regarding technology transfer and improvements in manufacturing processes.
- Collect, organize, and analyze data to prepare detailed reports for assigned quality processes.
- Document and implement improvements to quality systems and standard operating procedures, including maintaining SOPs for interactions with contract manufacturers.
- Gather and maintain documentation required for audits and inspections to ensure inspection readiness.
- Support special quality projects and contribute to continuous quality improvement initiatives.
Required Qualifications
- Bachelor’s degree or equivalent qualification in Engineering, Quality Management, Science or a related field demonstrating foundational technical knowledge.
- 2 years of practical experience or internships in quality assurance, manufacturing, or related operational environments.
- Strong attention to detail and ability to maintain accurate documentation.
- Basic understanding of investigations and automation processes.
- Ability to collect, organize, and analyze data effectively.
- Good communication skills to respond to routine technical inquiries.
- Ability to work independently.
- Ability to work night shifts and weekends.
Desired Qualifications
- Strong analytical mindset with the ability to interpret complex data and translate it into actionable quality improvements.
- Excellent communication skills to effectively collaborate with diverse teams and articulate quality concerns innovatively.
- Familiarity with quality systems, audits, and inspection readiness.
- Proactive learner with a passion for adopting emerging QA technologies and methodologies to drive shop floor excellence.
- Proactive approach to supporting special quality projects and continuous improvement.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Azhar
Email:
Internal Id: 26-04931
Immediate need for a talented Specialist 2, Quality Assurance. This is a 12+ Months Contract opportunity with long-term potential and is located in Fort Washington, PA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:26-07042
Pay Range: $22 - $32/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Responsible for maintaining quality records, assisting with corrective action plans, and supporting quality system improvements.
- Support work orders review and confirm area cleanliness after maintenance interventions.
- Collaborate with cross-functional teams to implement innovative quality assurance protocols on the shop floor, ensuring seamless production flow and minimal defects.
- Utilize data-driven insights to proactively identify potential quality issues and develop creative solutions to enhance product reliability.
- Engage in hands-on inspection of products, applying a keen eye for detail to uphold stringent quality standards.
- Performs batch records review and cleaning records review to ensure product availability.
- Support work orders review and confirm area cleanliness after maintenance interventions.
- Performs area walkthroughs to ensure audit readiness at all times.
- Contribute to continuous improvement initiatives by suggesting and piloting novel QA methodologies tailored to dynamic manufacturing environments.
- Document and communicate quality findings through clear, concise reports that facilitate swift decision-making and process optimization.
- Maintain accurate and timely quality records related to product inspections, nonconformance, and project outcomes.
- Assist in documenting, monitoring, and following up on corrective and preventive action plans to ensure their effective implementation and closure.
- Respond to routine inquiries regarding technology transfer and improvements in manufacturing processes.
- Collect, organize, and analyze data to prepare detailed reports for assigned quality processes.
- Document and implement improvements to quality systems and standard operating procedures, including maintaining SOPs for interactions with contract manufacturers.
- Gather and maintain documentation required for audits and inspections to ensure inspection readiness.
- Support special quality projects and contribute to continuous quality improvement initiatives.
Key Requirements and Technology Experience:
- Skills-Bachelor’s degree or equivalent qualification in Engineering, Quality Management, Science or a related field demonstrating foundational technical knowledge.
- 2 years of practical experience or internships in quality assurance, manufacturing, or related operational environments.
- Strong attention to detail and ability to maintain accurate documentation.
- Basic understanding of investigations and automation processes.
- Ability to collect, organize, and analyze data effectively.
- Good communication skills to respond to routine technical inquiries.
- Ability to work independently.
- Ability to work night shifts and weekends.
- Strong analytical mindset with the ability to interpret complex data and translate it into actionable quality improvements.
- Excellent communication skills to effectively collaborate with diverse teams and articulate quality concerns innovatively.
- Familiarity with quality systems, audits, and inspection readiness.
- Proactive learner with a passion for adopting emerging QA technologies and methodologies to drive shop floor excellence.
- Proactive approach to supporting special quality projects and continuous improvement.
Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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